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

Prealbumin, Antigen, Antiserum, Control

21 CFR 866.5060 / Immunology
FDA source (opens on fda.gov)

JZJ is the FDA product code for Prealbumin, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5060. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JZJ
Device name
Prealbumin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5060
Device class
Class I
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
1

Clearances, product code JZJ

By decision year
11 clearances under product code JZJ with a decision year between 1978 and 2000, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JZJ by decision year
YearClearances
19781
19831
19852
19883
19911
19951
19981
20001

Applicants with the most clearances

Product code JZJ
Applicants holding the most 510(k) clearances under product code JZJ
ApplicantClearances
Atlantic Antibodies2
Kent Laboratories, Inc.2
Abbott Medical1
Behring Diagnostics, Inc.1
Boehringer Mannheim Corp.1
Hyland Therapeutic Div., Travenol Laboratories1
Kallestad Diag, A Div. of Erbamont, Inc.1
Randox Laboratories, Limited1
The Binding Site1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order