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510(k) K840257

RAPID IMMUNO-ASSAY SYS by Applied Polytechnology, Inc. — Product Code LLG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1984
Date Received
January 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Igg, Platelet Associated
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Applied Polytechnology, Inc.

  • K860483 — FILTRA-CHECK-UTI (April 4, 1986)
  • K843833 — BACTERIURIA DETECT DEVICE, MULTI SAMPLER (November 29, 1984)
  • K843834 — BACTERIURIA DETECT. DEVICE APTEK II (November 29, 1984)
  • K843359 — URINE TRANSPORT KIT (September 27, 1984)
  • K843316 — INDOLE SPOT TEST KIT 270-25 (September 11, 1984)
  • K834264 — REVERSE-FLOW SYSTEM (January 13, 1984)

Other clearances for product code LLG

  • K841465 — GENERAL DIAGNOSTICS PLATELET ANTIBODY (July 2, 1984)