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510(k) K852843

GENERAL DIAGNOSTICS COAG-A-MATE XC by Warner-Lambert Co. — Product Code KQC

K852843 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "GENERAL DIAGNOSTICS COAG-A-MATE XC". The FDA issued a decision of Substantially Equivalent on August 13, 1985. The device falls under product code KQC (Stains, Hematology), a Class I device regulated under 21 CFR 864.1850. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1985
Date Received
July 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Hematology
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Warner-Lambert Co.

  • K024160 — NEOSPORIN SCAR SOLUTION (March 17, 2003)
  • K893452 — EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM (June 22, 1989)
  • K870584 — O.P.T.(TM) OVULATION PREDICTION TEST (November 25, 1987)
  • K861510 — MULTILUMEN VIAPIC CENTRAL LINE CATHETER (June 9, 1986)
  • K852967 — GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK (August 19, 1985)
  • K852689 — GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK (August 19, 1985)
  • K852889 — GENERAL DIAGNOSTICS RAPID E. COLI TEST (July 23, 1985)
  • K850486 — GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY (May 8, 1985)
  • K850411 — GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY (May 8, 1985)
  • K850410 — GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY (May 8, 1985)

Other clearances for product code KQC

  • K882873 — FIELDTEX HEMATOXYLIN (July 28, 1988)
  • K843619 — RETIC-SET (October 30, 1984)
  • K841848 — RETIC-SET (May 31, 1984)
  • K792550 — PONCEAU S STAIN SET (January 16, 1980)
  • K792496 — VOLU-SOL NMB RETICULOCYTE STAIN (December 31, 1979)
  • K791007 — STAT DIFF STAIN (August 3, 1979)
  • K760485 — HEMASTAIN FIXATIVE (August 30, 1976)
  • K760487 — HEMASTAIN PHOSPHATE BUFFER (August 30, 1976)

FDA data resources