510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771867Substantially Equivalent

Mycoplasma Detection Kit

Bioassay Systems Research Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771867 is the FDA 510(k) clearance record for MYCOPLASMA DETECTION KIT, a class I device, cleared for Bioassay Systems Research Corp. on under FDA product code KPB (Media And Components, Mycoplasma Detection). FDA records list 3 510(k) clearances for Bioassay Systems Research Corp., from to . As of , FDA records show no recalls naming K771867.

Clearance record

Decision date
Received
(45 days to decision)
Product code
KPB Media And Components, Mycoplasma Detection
Regulation
21 CFR 864.2360
Device class
Class I
Review panel
Hematology
Applicant
Bioassay Systems Research Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KPB

Trailing 12 months

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

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