510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821849Substantially Equivalent

Ebv-Vca Antibody Assay Kit

Biotech Research Laboratories, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821849 is the FDA 510(k) clearance record for EBV-VCA ANTIBODY ASSAY KIT, a class I device, cleared for Biotech Research Laboratories, Inc. on under FDA product code JRY (Antiserum, Fluorescent, Epstein-Barr Virus). FDA records list 2 510(k) clearances for Biotech Research Laboratories, Inc., from to . As of , FDA records show no recalls naming K821849.

Clearance record

Decision date
Received
(50 days to decision)
Product code
JRY Antiserum, Fluorescent, Epstein-Barr Virus
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Biotech Research Laboratories, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JRY

Trailing 12 months

FDA records hold no clearances under product code JRY in the trailing twelve months.

FDA records show no clearances under product code JRY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JRY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260