510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CHPClass I

Radioimmunoassay, Estradiol

21 CFR 862.1260 / Clinical Chemistry
FDA source (opens on fda.gov)

CHP is the FDA product code for Radioimmunoassay, Estradiol, a class I device type, regulated under 21 CFR 862.1260. As of , FDA records hold 50 510(k) clearances under this code, the most recent dated , and 31 recalls.

Classification record

Product code
CHP
Device name
Radioimmunoassay, Estradiol
Regulation
21 CFR 862.1260
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
50
Ingested recalls
31

Clearances, product code CHP

By decision year
50 clearances under product code CHP with a decision year between 1979 and 2004, 1993 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code CHP by decision year
YearClearances
19792
19801
19812
19821
19843
19853
19862
19871
19884
19893
19901
19915
19921
19936
19942
19955
19961
19976
20041

Applicants with the most clearances

Product code CHP
Applicants holding the most 510(k) clearances under product code CHP
ApplicantClearances
Siemens Healthcare Diagnostics Inc.5
Serono-Baker Diagnostics, Inc.4
Diagnostic Systems Laboratories, Inc.3
Amersham Corp.2
Biomerieux Vitek, Inc.2
Boehringer Mannheim Corp.2
Ciba Corning Diagnostics Corp.2
Pantex, Div. Bio-Analysis, Inc.2
Pharmacia, Inc.2
Serono Laboratories, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 48 companies shown, in name order