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

Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes

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

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

Classification record

Product code
CJK
Device name
Phenolphthalein Phosphate, 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
1
Ingested recalls
0

Clearances, product code CJK

By decision year
1 clearance under product code CJK with a decision year between 1988 and 1988, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CJK by decision year
YearClearances
19881

Applicants with the most clearances

Product code CJK
Applicants holding the most 510(k) clearances under product code CJK
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1

Companies listing this code with FDA

Companies whose registered establishments list this code