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510(k) K850411

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

K850411 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY". The FDA issued a decision of Substantially Equivalent on May 8, 1985. The device falls under product code LGP (Assay, Alpha-2-Antiplasmin), a Class II device regulated under 21 CFR 864.5425. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.

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

Other clearances by Warner-Lambert Co.

  • K024160 — NEOSPORIN SCAR SOLUTION (March 17, 2003)
  • K893452 — EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM (June 22, 1989)
  • K870584 — O.P.T.(TM) OVULATION PREDICTION TEST (November 25, 1987)
  • K861510 — MULTILUMEN VIAPIC CENTRAL LINE CATHETER (June 9, 1986)
  • K852967 — GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK (August 19, 1985)
  • K852689 — GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK (August 19, 1985)
  • K852843 — GENERAL DIAGNOSTICS COAG-A-MATE XC (August 13, 1985)
  • K852889 — GENERAL DIAGNOSTICS RAPID E. COLI TEST (July 23, 1985)
  • K850410 — GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY (May 8, 1985)
  • K850486 — GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY (May 8, 1985)

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)

FDA data resources