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510(k) K851504

VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 by Ncs Diagnostics, Inc. — Product Code GMP

K851504 is an FDA 510(k) premarket notification submitted by Ncs Diagnostics, Inc. for the device "VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010". The FDA issued a decision of Substantially Equivalent on August 19, 1985. The device falls under product code GMP (Antisera, Control For Nontreponemal Tests), a Class II device regulated under 21 CFR 866.3820. Ncs Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1985
Date Received
April 15, 1985
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 Ncs Diagnostics, Inc.

  • K943498 — KULTSURE STARSWAB (M210), MODIFICATION (November 30, 1994)
  • K943499 — KULTSURE STARSWAB(M240), MODIFICATION (November 30, 1994)
  • K882811 — STREPSLIDE (October 25, 1988)
  • K881209 — ASO SLIDE TEST (April 12, 1988)
  • K874019 — STAPHSLIDE (October 28, 1987)
  • K871404 — KULTSURE (April 21, 1987)
  • K870231 — KULTSURE (February 4, 1987)
  • K860178 — KULTSURE (CULTURE TRANSPORT) (April 4, 1986)
  • K860655 — KULTSURE (CATALOGUE NO. M200) (March 6, 1986)
  • K860656 — KULTSURE (CATALOGUE NO. M210) (March 4, 1986)

Other clearances for product code GMP

  • K980638 — ADI SYPHILIS RPR LIQUID CONTROLS (July 6, 1998)
  • K961998 — QUALITROL SYPHSERO CONTROL SET (August 8, 1996)
  • 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)
  • 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