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510(k) K823794

CONTROL TM 8 by General Diagnostics — Product Code GLQ

K823794 is an FDA 510(k) premarket notification submitted by General Diagnostics for the device "CONTROL TM 8". The FDA issued a decision of Substantially Equivalent on January 14, 1983. The device falls under product code GLQ (Mixture, Control, White-Cell And Red-Cell Indices), a Class II device regulated under 21 CFR 864.8625. General Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
December 16, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixture, Control, White-Cell And Red-Cell Indices
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by General Diagnostics

  • K882663 — BARBITURATE ENZYME IMMUNOASSAY KIT (September 19, 1988)
  • K872882 — CANNABINOID ENZYME IMMUNOASSAY KIT (November 3, 1987)
  • K871305 — COCAINE METABOLITE ENZYME IMMUNOASSAY KIT (June 5, 1987)
  • K864993 — QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE (March 31, 1987)
  • K863877 — BENZODIAZEPINE ENZYME IMMUNOASSAY KIT (March 12, 1987)
  • K842307 — GENERAL DIAG. CEFONICID 30MCG ANTIMIC (July 20, 1984)
  • K841465 — GENERAL DIAGNOSTICS PLATELET ANTIBODY (July 2, 1984)
  • K833709 — CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK (December 30, 1983)
  • K832653 — CEFUROXIME 30MCG. SUSCEP DISK (October 14, 1983)
  • K831179 — CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP (May 9, 1983)

Other clearances for product code GLQ

  • K111211 — CELL-DYN 22 PLUS CONTROL (December 22, 2011)
  • K110718 — CELL-CHEX WITH CPPD CRYSTALS (May 26, 2011)
  • K101335 — CELL-CHEX (August 23, 2010)
  • K090137 — STAK-CHEX PLUS RETICS (March 18, 2009)
  • K000945 — PARA 12 PLUS RETICS (April 18, 2000)
  • K994388 — XE CHECK (January 14, 2000)
  • K992887 — STAK-CHEX PLUS RETICS (November 22, 1999)
  • K823587 — UNI-CELL (January 5, 1983)
  • K823498 — PARA 12 (December 28, 1982)

FDA data resources