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510(k) K961544

QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 by Consolidated Technologies, Inc. — Product Code DGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1996
Date Received
April 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Whole Human Serum, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5700
Review Panel
HE
Submission Type

Other clearances by Consolidated Technologies, Inc.

  • K000116 — QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 (February 15, 2000)
  • K992578 — URINE CHEMISTRY CONTROL, LEVEL 2 (September 3, 1999)
  • K992576 — URINE CHEMISTRY CONTROL, LEVEL 1 (September 3, 1999)
  • K992151 — REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE (July 14, 1999)
  • K981339 — QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 (April 21, 1998)
  • K974699 — REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE (January 22, 1998)
  • K973469 — QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UN (September 25, 1997)
  • K972146 — QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS (July 8, 1997)
  • K972080 — QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONT (June 18, 1997)
  • K961815 — QUALITROL ANA CONTROL SERUM SET (September 27, 1996)

Other clearances for product code DGR

  • K902220 — PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL (September 5, 1990)
  • K865014 — LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II (January 9, 1987)
  • K790298 — RADIOASSAY, CONTROL SERUM I, II, III (April 4, 1979)
  • K781355 — ICS NORMAL CONTROL SERUM (August 31, 1978)