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510(k) K770394

THROMBO-SCREEN AT-111 KIT by Bay Area Hema. Onco. Clinic. & Res. L — Product Code JBQ

K770394 is an FDA 510(k) premarket notification submitted by Bay Area Hema. Onco. Clinic. & Res. L for the device "THROMBO-SCREEN AT-111 KIT". The FDA issued a decision of Substantially Equivalent on March 30, 1977. The device falls under product code JBQ (Antithrombin Iii Quantitation), a Class II device regulated under 21 CFR 864.7060. Bay Area Hema. Onco. Clinic. & Res. L has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1977
Date Received
February 28, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antithrombin Iii Quantitation
Device Class
Class II
Regulation Number
864.7060
Review Panel
HE
Submission Type

Other clearances by Bay Area Hema. Onco. Clinic. & Res. L

  • K771678 — THROMBO-SCREEN PLATELET ADHESION (November 22, 1977)
  • K770722 — THROMBO SCREEN QUANTITATIVE HEPARIN ASSA (July 11, 1977)
  • K770395 — THROMBO-CETIN (RISTOCETIN) (March 21, 1977)

Other clearances for product code JBQ

  • K242952 — INNOVANCE Antithrombin (March 28, 2025)
  • K081769 — INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 (May 28, 2009)
  • K070301 — HEMOSIL ANTITHROMBIN (February 23, 2007)
  • K062431 — HEMOSIL LIQUID ANTITHROMBIN (September 1, 2006)
  • K043007 — BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE (November 7, 2005)
  • K033775 — HEMOSIL LIQUID ANTITHROMBIN XL (January 2, 2004)
  • K023991 — CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (April 28, 2003)
  • K022550 — COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (August 27, 2002)
  • K022195 — COAMATIC AT-400 (August 7, 2002)
  • K994238 — IL TEST LIQUID ANTITHROMBIN (June 23, 2000)

FDA data resources