510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832771Substantially Equivalent

Erythrocyte Test

Bio-Analytics Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832771 is the FDA 510(k) clearance record for ERYTHROCYTE TEST, a class II device, cleared for Bio-Analytics Laboratories, Inc. on under FDA product code LKZ (Red-Cell Count By Photometry). FDA records list 19 510(k) clearances for Bio-Analytics Laboratories, Inc., from to . As of , FDA records show no recalls naming K832771.

Clearance record

Decision date
Received
(73 days to decision)
Product code
LKZ Red-Cell Count By Photometry
Regulation
21 CFR 864.7100
Device class
Class II
Review panel
Hematology
Applicant
Bio-Analytics Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LKZ

Trailing 12 months

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

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