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

Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes

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

CJO is the FDA product code for Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes, a class II device type, regulated under 21 CFR 862.1050. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
CJO
Device name
Alpha-Naphthyl 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
4
Ingested recalls
1

Clearances, product code CJO

By decision year
4 clearances under product code CJO with a decision year between 1977 and 2012, 2012 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code CJO by decision year
YearClearances
19771
19991
20122

Applicants with the most clearances

Product code CJO
Applicants holding the most 510(k) clearances under product code CJO
ApplicantClearances
Siemens Healthcare Diagnostics Inc.2
Bayer Corp.1
Gelman Instrument Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code