510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780665Substantially Equivalent

Recap

Bca Biological Corp. of America, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780665 is the FDA 510(k) clearance record for RECAP, a class II device, cleared for Bca Biological Corp. of America on under FDA product code KSF (Kit, Quality Control For Blood Banking Reagents). FDA records list one 510(k) clearance for Bca Biological Corp. of America. As of , FDA records show no recalls naming K780665.

Clearance record

Decision date
Received
(46 days to decision)
Product code
KSF Kit, Quality Control For Blood Banking Reagents
Regulation
21 CFR 864.9650
Device class
Class II
Review panel
Hematology
Applicant
Bca Biological Corp. of America 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KSF

Trailing 12 months

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

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