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510(k) K881829

PAT PLATELET AGGREGATION TEST by Streck Laboratories, Inc. — Product Code JBX

K881829 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "PAT PLATELET AGGREGATION TEST". The FDA issued a decision of Substantially Equivalent on July 1, 1988. The device falls under product code JBX (Aggregrometer, Platelet), a Class II device regulated under 21 CFR 864.6675. Streck Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1988
Date Received
April 29, 1988
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 Streck Laboratories, Inc.

  • K042587 — RETIC-CHEX FOR CELL-DYN (October 19, 2004)
  • K040107 — CYTO-CHEX BCT (July 27, 2004)
  • K040025 — A1C-CELLULAR (March 2, 2004)
  • K023656 — SICKLE-CHEX SOLUBILITY KIT (December 30, 2002)
  • K021922 — MODIFICATION TO PARA 5X (June 25, 2002)
  • K020469 — CAL-CHEX CD PLUS (April 4, 2002)
  • K013316 — SICKLE-CHEX (November 6, 2001)
  • K011410 — PARA 5X (June 26, 2001)
  • K001443 — SUGAR CHEX ONE (June 29, 2000)
  • K000945 — PARA 12 PLUS RETICS (April 18, 2000)

Other clearances for product code JBX

  • K932566 — AGGRO/LINK CONTROL SOFTWARE (November 2, 1993)
  • K912774 — ARACHIDONIC ACID (August 22, 1991)
  • 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)
  • K811290 — ARACHIDONIC ACID (July 27, 1981)
  • K781710 — BUFFER, COLLAGEN REAGENT AND DILUENT (October 24, 1978)

FDA data resources