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

Acid Phosphatase, Naphthyl Phosphate

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

CKB is the FDA product code for Acid Phosphatase, Naphthyl Phosphate, a class II device type, regulated under 21 CFR 862.1020. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
CKB
Device name
Acid Phosphatase, Naphthyl Phosphate
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
24
Ingested recalls
2

Clearances, product code CKB

By decision year
24 clearances under product code CKB with a decision year between 1982 and 2006, 1982 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CKB by decision year
YearClearances
19823
19831
19841
19852
19863
19883
19892
19902
19961
19971
19982
19991
20031
20061

Applicants with the most clearances

Product code CKB
Applicants holding the most 510(k) clearances under product code CKB
ApplicantClearances
Data Medical Associates, Inc.2
OLYMPUS Corporation of the Americas2
Abbott Diagnostics Mfg., Inc.1
American Dade1
Bayer Diagnostics Corp.1
Siemens Healthcare Diagnostics Inc.1
Boehringer Mannheim Corp.1
Cooper Biomedical, Inc.1
Crestat Diagnostics, Inc.1
Diagnostic Chemicals, Ltd. (USA)1

Companies listing this code with FDA

Companies whose registered establishments list this code