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510(k) K801425

RH CONTROL by North American Biologicals, Inc. — Product Code KSF

K801425 is an FDA 510(k) premarket notification submitted by North American Biologicals, Inc. for the device "RH CONTROL". The FDA issued a decision of Substantially Equivalent on July 14, 1980. The device falls under product code KSF (Kit, Quality Control For Blood Banking Reagents), a Class II device regulated under 21 CFR 864.9650. North American Biologicals, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1980
Date Received
June 17, 1980
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 by North American Biologicals, Inc.

  • K820301 — PLASMA POOLER HEAT SEALER (April 9, 1982)
  • K801219 — PLASMAPOOLER (October 31, 1980)
  • K781896 — BLOOD GROUP SUBSTANCE A,B (December 20, 1978)
  • K781895 — BLOOD GROUP SUBSTANCE B (December 20, 1978)
  • K781862 — BLOOD GROUP SUBSTANCE A (December 20, 1978)

Other clearances for product code KSF

  • K811713 — AVI-D CONTROL (October 23, 1981)
  • K810599 — DADE RH CONTROL REAGENT (March 31, 1981)
  • 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)
  • K780665 — RECAP (June 6, 1978)
  • K780097 — QUALITY CONTROL SYSTEM, SPECTRA (April 24, 1978)
  • K771814 — REAGENT CONFIDENCE SERA (November 7, 1977)

FDA data resources