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510(k) K831363

TESTCORP ASO by Catheter Technology Corp. — Product Code GTQ

K831363 is an FDA 510(k) premarket notification submitted by Catheter Technology Corp. for the device "TESTCORP ASO". The FDA issued a decision of Substantially Equivalent on May 16, 1983. The device falls under product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent), a Class I device regulated under 21 CFR 866.3720. Catheter Technology Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1983
Date Received
April 26, 1983
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 Catheter Technology Corp.

  • K880571 — CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM (March 4, 1988)
  • K871080 — PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (August 12, 1987)
  • K871998 — GROSHONG CV CATHETER REPAIR KIT (June 24, 1987)
  • K860256 — BRAWN AND GROSHONG CATHETERS (March 28, 1986)
  • K842577 — CATH-TECH POLYURETHANE UMBILICAL VESS (March 13, 1985)
  • K842147 — CATH-TECH CHOLANGIOGRAPHY CATHETER (October 2, 1984)
  • K840339 — UMBILICAL VESSEL CATHETER (July 25, 1984)
  • K831386 — GROSHONG CATHETER, LONG TERM TYPE (October 14, 1983)
  • K831365 — TESTCORP ANA (June 2, 1983)
  • K831366 — TESTCORP PREG (June 2, 1983)

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