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510(k) K850411

GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY by Warner-Lambert Co. — Product Code LGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1985
Date Received
February 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Alpha-2-Antiplasmin
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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Other clearances for product code LGP

  • K864213 — IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY (November 25, 1986)
  • K833890 — COATEST ANTIPLASMIN (January 30, 1984)
  • K803110 — PROTEOLYTIC ENZYME CONTROL (February 17, 1981)
  • K802840 — ALPHA-ANTIPLASM ASSAY (February 17, 1981)