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510(k) K961998

QUALITROL SYPHSERO CONTROL SET by Consolidated Technologies, Inc. — Product Code GMP

K961998 is an FDA 510(k) premarket notification submitted by Consolidated Technologies, Inc. for the device "QUALITROL SYPHSERO CONTROL SET". The FDA issued a decision of Substantially Equivalent on August 8, 1996. The device falls under product code GMP (Antisera, Control For Nontreponemal Tests), a Class II device regulated under 21 CFR 866.3820. Consolidated Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1996
Date Received
May 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Control For Nontreponemal Tests
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

Other clearances by Consolidated Technologies, Inc.

  • K000116 — QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 (February 15, 2000)
  • K992576 — URINE CHEMISTRY CONTROL, LEVEL 1 (September 3, 1999)
  • K992578 — URINE CHEMISTRY CONTROL, LEVEL 2 (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 GMP

  • K980638 — ADI SYPHILIS RPR LIQUID CONTROLS (July 6, 1998)
  • K955143 — RPR LIQUID CONTROLS (July 30, 1996)
  • K885298 — VISUWELL REAGIN TEST 960 TEST KIT (March 15, 1989)
  • K875180 — V-TREND RPRL CARD TEST (February 4, 1988)
  • K851504 — VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 (August 19, 1985)
  • K843741 — RPR TEST REDITEST (October 25, 1984)
  • K812425 — BECKMAN R.PR CONTROL SERUM SET (September 23, 1981)
  • K810119 — CONTROL SERUMS FOR NONTREPONEMAL TEST (February 9, 1981)

FDA data resources