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510(k) K801928

LAB-TEK FTA-ABS KIT by Miles Laboratories, Inc. — Product Code JWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
August 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Treponema Pallidum For Fta-Abs Test
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K864530 — SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (February 18, 1987)

Other clearances for product code JWL

  • K831296 — POLYCHACO FIA-ABS TEST FOR SYPHILIS (July 26, 1983)
  • K801959 — FTA-ABS TEST (October 23, 1980)
  • K802276 — FTA-ABS BIOPAK (October 23, 1980)