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

Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

21 CFR 862.1050 / Clinical Chemistry
FDA source (opens on fda.gov)

CKF is the FDA product code for Phenylphosphate, Alkaline Phosphatase Or Isoenzymes, a class II device type, regulated under 21 CFR 862.1050. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CKF
Device name
Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
Regulation
21 CFR 862.1050
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code CKF

By decision year
2 clearances under product code CKF with a decision year between 1996 and 2008, 1996 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CKF by decision year
YearClearances
19961
20081

Applicants with the most clearances

Product code CKF
Applicants holding the most 510(k) clearances under product code CKF
ApplicantClearances
Alfa Wassermann Diagnostic Technologies, Inc.1
Hichem Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code