Device classification

Radioimmunoassay, Human Growth Hormone

Clinical Chemistry · 21 CFR 862.1370

Class IProduct code CFLExempt
Open FDA's page for this record
Third party flag
N
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
CFL
Review panel
CH
Medical specialty
CH
Device name
Radioimmunoassay, Human Growth Hormone
Medical specialty description
Clinical Chemistry
Device class
1
Regulation number
862.1370
Implant flag
N
Submission type ID
4
Harmonized identifiers (openFDA)
K number
K972761, K961172, K955390, K970701, K875229, K955376, K841088, K960551, K961678, K852299, K950228, K780347, K821366, K951707, K851259, K921868, K971353, K951752, K912858, K882823, K841094, K831073, K930484, K860228, K920299, K896808, K946247, K803280, K962758, K850892, K950510, K905098, K905757, K896643, K952505, K930047
Registration number
1036362, 2432235, 3008198807, 3014325803, 3002806944, 1222302, 9612316, 2122870, 8010132, 3006198300, 3003741796, 3017894300, 3022178699, 3005529799, 3009491259, 8031673, 1832216, 3007118747, 2029372, 3009984016, 8021924, 9610126, 3002800697, 2020726, 3017019647, 2032839, 3004434309, 9610240, 2245285
FEI number
3004185580, 1036362, 3002485711, 2432235, 3008198807, 3014325803, 3002806944, 2967, 2122870, 3006198300, 1000306617, 1000121039, 3002806559, 3003741796, 3002806808, 3017894300, 3022178699, 3005529799, 3009491259, 1832216, 3007118747, 3009984016, 3002808212, 3002800697, 2020726, 3017019647, 3004434309, 3002808328, 2245285
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.