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510(k) K843732

API UNISCEPT MIC by Analytical Products, Inc. — Product Code LTD

K843732 is an FDA 510(k) premarket notification submitted by Analytical Products, Inc. for the device "API UNISCEPT MIC". The FDA issued a decision of Substantially Equivalent on October 24, 1984. The device falls under product code LTD (Paraquat Assay), a Class III device. Analytical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1984
Date Received
September 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Paraquat Assay
Device Class
Class III
Regulation Number
Review Panel
TX
Submission Type

Other clearances by Analytical Products, Inc.

  • K924814 — API 20E/UNISCEPT 20E (March 11, 1993)
  • K923684 — API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC (December 3, 1992)
  • K922926 — API UNISCEPT KB/TYPE 2 AND 3 (October 13, 1992)
  • K901559 — MODIFICATION TO API UNISCEPT 20GP (September 10, 1990)
  • K901390 — DMAC INDOLE REAGENT (April 16, 1990)
  • K895796 — API UNISCEPT KB (November 13, 1989)
  • K884510 — MODIFICATION MICRO-MIC (November 22, 1988)
  • K884509 — MODIFICATION MIC/API UNISCEPT(R) (November 22, 1988)
  • K880598 — MODIFICATIONS TO API UNISCEPT (R) KB (March 23, 1988)
  • K874466 — API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC (December 9, 1987)

Other clearances for product code LTD

  • K843612 — MODIFICATION OF ABL MIC-10 PRECEPT SYS (February 19, 1985)

FDA data resources