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510(k) K780665

RECAP by Bca Biological Corp. of America — Product Code KSF

K780665 is an FDA 510(k) premarket notification submitted by Bca Biological Corp. of America for the device "RECAP". The FDA issued a decision of Substantially Equivalent on June 6, 1978. The device falls under product code KSF (Kit, Quality Control For Blood Banking Reagents), a Class II device regulated under 21 CFR 864.9650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1978
Date Received
April 21, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Quality Control For Blood Banking Reagents
Device Class
Class II
Regulation Number
864.9650
Review Panel
HE
Submission Type

Other clearances for product code KSF

  • K811713 — AVI-D CONTROL (October 23, 1981)
  • K810599 — DADE RH CONTROL REAGENT (March 31, 1981)
  • K801425 — RH CONTROL (July 14, 1980)
  • K800658 — RST-SERIES CONTROL (April 16, 1980)
  • K800310 — ORTHO ANTISERA CONTROL (March 5, 1980)
  • K800239 — RH-HR NEGATIVE CONTROL REAGENT (February 21, 1980)
  • K790249 — TEST CELLS (May 16, 1979)
  • K790025 — COUNTER CHECK, H001, H002, H003 (January 17, 1979)
  • K780097 — QUALITY CONTROL SYSTEM, SPECTRA (April 24, 1978)
  • K771814 — REAGENT CONFIDENCE SERA (November 7, 1977)

FDA data resources