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510(k) K811290

ARACHIDONIC ACID by Bio/Data Corp. — Product Code JBX

K811290 is an FDA 510(k) premarket notification submitted by Bio/Data Corp. for the device "ARACHIDONIC ACID". The FDA issued a decision of Substantially Equivalent on July 27, 1981. The device falls under product code JBX (Aggregrometer, Platelet), a Class II device regulated under 21 CFR 864.6675. Bio/Data Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1981
Date Received
May 11, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aggregrometer, Platelet
Device Class
Class II
Regulation Number
864.6675
Review Panel
HE
Submission Type

Other clearances by Bio/Data Corp.

  • K001891 — MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C (July 12, 2000)
  • K943153 — MICROSAMPLE COAGULATION ANALYZER (March 24, 1995)
  • K893650 — PLATELET AGGREGATION PROFILER MODEL PAP-4C (June 23, 1989)
  • K881150 — KINETIC FIBRINOGEN ASSAY (March 28, 1988)
  • K873382 — PLATELET EXTRACT REAGENT (November 20, 1987)
  • K860751 — VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA (March 18, 1986)
  • K860342 — MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP (March 4, 1986)
  • K854546 — MICROSAMPLE COAGULATION ANALYSER MODEL 110P (January 7, 1986)
  • K853897 — CITREX H (October 10, 1985)
  • K853246 — CALCIUM CHLORIDE (August 13, 1985)

Other clearances for product code JBX

  • K932566 — AGGRO/LINK CONTROL SOFTWARE (November 2, 1993)
  • K912774 — ARACHIDONIC ACID (August 22, 1991)
  • K881829 — PAT PLATELET AGGREGATION TEST (July 1, 1988)
  • K862775 — ASSERACHROM B-TG KIT (October 22, 1986)
  • K851025 — AGGRO/LINK COMPUTER INTERFACE (June 12, 1985)
  • K850592 — PLATELET AGGREGATION REAGENT (May 13, 1985)
  • K832929 — RISTOCETIN PLATELET AGGREGA-REAGENT TEST (September 29, 1983)
  • K830749 — PLATELET AGGREGOMETER (May 16, 1983)
  • K821005 — PLATELET AGGREGATION PROFILER #PAP-4 (June 1, 1982)
  • K781710 — BUFFER, COLLAGEN REAGENT AND DILUENT (October 24, 1978)

FDA data resources