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510(k) K862530

RAPID AS LATEX by Dilab, Inc. — Product Code GTQ

K862530 is an FDA 510(k) premarket notification submitted by Dilab, Inc. for the device "RAPID AS LATEX". The FDA issued a decision of Substantially Equivalent on April 21, 1987. The device falls under product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent), a Class I device regulated under 21 CFR 866.3720. Dilab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1987
Date Received
July 2, 1986
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 Dilab, Inc.

  • K850931 — ALBUMIN (June 26, 1985)
  • K850934 — PHOSPHORUS (June 25, 1985)
  • K850938 — CHOLESTEROL (June 25, 1985)
  • K850932 — CREATININE (June 25, 1985)
  • K850933 — URIC ACID (June 25, 1985)
  • K850936 — TOTAL PROTEINS (June 25, 1985)
  • K850930 — GLUCOSE (June 10, 1985)
  • K850935 — CHLORIDE (June 10, 1985)
  • K850929 — CALCIUM (June 10, 1985)
  • K850937 — UREA (June 10, 1985)

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