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

Whole Human Serum, Antigen, Antiserum, Control

21 CFR 866.5700 / Immunology
FDA source (opens on fda.gov)

DGR is the FDA product code for Whole Human Serum, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5700. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DGR
Device name
Whole Human Serum, Antigen, Antiserum, Control
Regulation
21 CFR 866.5700
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
5
Ingested recalls
0

Clearances, product code DGR

By decision year
5 clearances under product code DGR with a decision year between 1978 and 1996, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DGR by decision year
YearClearances
19781
19791
19871
19901
19961

Applicants with the most clearances

Product code DGR
Applicants holding the most 510(k) clearances under product code DGR
ApplicantClearances
Beckman Instruments, Inc.1
Bio-Rad1
Boehringer Mannheim Corp.1
Consolidated Technologies, Inc.1
Kallestad Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order