510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K821534Substantially Equivalent

Hematology Data Management Sys

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

K821534 is the FDA 510(k) clearance record for HEMATOLOGY DATA MANAGEMENT SYS, a class II device, cleared for Biovation, Inc. on under FDA product code JGP (Lowry (Colorimetric), Total Protein). FDA records list 11 510(k) clearances for Biovation, Inc., from to . As of , FDA records show no recalls naming K821534.

Clearance record

Decision date
Received
(17 days to decision)
Product code
JGP Lowry (Colorimetric), Total Protein
Regulation
21 CFR 862.1635
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Biovation, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JGP

Trailing 12 months

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

FDA records show no clearances under product code JGP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JGP, 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