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510(k) K881209

ASO SLIDE TEST by Ncs Diagnostics, Inc. — Product Code GTQ

K881209 is an FDA 510(k) premarket notification submitted by Ncs Diagnostics, Inc. for the device "ASO SLIDE TEST". The FDA issued a decision of Substantially Equivalent on April 12, 1988. The device falls under product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent), a Class I device regulated under 21 CFR 866.3720. Ncs Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1988
Date Received
March 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antistreptolysin - Titer/Streptolysin O Reagent
Device Class
Class I
Regulation Number
866.3720
Review Panel
MI
Submission Type

Other clearances by Ncs Diagnostics, Inc.

  • K943499 — KULTSURE STARSWAB(M240), MODIFICATION (November 30, 1994)
  • K943498 — KULTSURE STARSWAB (M210), MODIFICATION (November 30, 1994)
  • K882811 — STREPSLIDE (October 25, 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)
  • K860657 — KULTSURE (CATALOGUE NO. M240) (March 4, 1986)
  • K860656 — KULTSURE (CATALOGUE NO. M210) (March 4, 1986)

Other clearances for product code GTQ

  • K052645 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PROD (December 14, 2005)
  • K953437 — OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT (October 20, 1995)
  • K915742 — TURBIQUANT ASL (June 28, 1993)
  • K926236 — BECKMAN ANTI-STREPTOLYSIN O KIT (June 15, 1993)
  • K924247 — ACCUTEX ASO LATEX TEST (December 7, 1992)
  • K922723 — TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (September 18, 1992)
  • K915053 — BECKMAN ANTISTREPTOLYSIN O, MODIFICATION (March 19, 1992)
  • K912150 — BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT (July 17, 1991)
  • K904416 — CROATEST (R) RHEUMATOID DIAGNOSTIC (June 24, 1991)
  • K910885 — QM300 CALIBRATOR G PACK (June 17, 1991)

FDA data resources