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510(k) K800239

RH-HR NEGATIVE CONTROL REAGENT by Gotham Biologics, Inc. — Product Code KSF

K800239 is an FDA 510(k) premarket notification submitted by Gotham Biologics, Inc. for the device "RH-HR NEGATIVE CONTROL REAGENT". The FDA issued a decision of Substantially Equivalent on February 21, 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. Gotham Biologics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1980
Date Received
February 5, 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 Gotham Biologics, Inc.

  • K800189 — BOVINE ALBUMIN 22% & 30% SOLUTIONS (February 13, 1980)

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)
  • 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