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

Acid Phosphatase, Thymolphthale Inmonophosphate

21 CFR 862.1020 / Clinical Chemistry
FDA source (opens on fda.gov)

CKE is the FDA product code for Acid Phosphatase, Thymolphthale Inmonophosphate, a class II device type, regulated under 21 CFR 862.1020. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CKE
Device name
Acid Phosphatase, Thymolphthale Inmonophosphate
Regulation
21 CFR 862.1020
Device class
Class II
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
9
Ingested recalls
0

Clearances, product code CKE

By decision year
9 clearances under product code CKE with a decision year between 1979 and 1992, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code CKE by decision year
YearClearances
19791
19801
19821
19841
19862
19881
19922

Applicants with the most clearances

Product code CKE
Applicants holding the most 510(k) clearances under product code CKE
ApplicantClearances
Anco Medical Reagents & Assoc.1
Data Medical Associates, Inc.1
Diagnostic Chemicals, Ltd. (USA)1
E.I. Dupont de Nemours & Co., Inc.1
Eastman Kodak Company1
King Diagnostics, Inc.1
Stanbio Laboratory1
Sterling Diagnostics, Inc.1
Tech Intl. Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code