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510(k) K850347

API UNISCEPT KB by Analytical Products, Inc. — Product Code LTW

K850347 is an FDA 510(k) premarket notification submitted by Analytical Products, Inc. for the device "API UNISCEPT KB". The FDA issued a decision of Substantially Equivalent on March 26, 1985. The device falls under product code LTW (Susceptibility Test Cards, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Analytical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1985
Date Received
January 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Cards, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
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 LTW

  • K852613 — MIC-CONCEPT SYSTEM (September 20, 1985)
  • K853273 — PRECEPT CEFTRIAXONE (September 16, 1985)
  • K853772 — PRECEPT METHICILLIN (September 16, 1985)
  • K853685 — PRECEPT TM CARBENICILLIN (September 16, 1985)
  • K853596 — PRECEPT CEFOPERAZONE (September 16, 1985)
  • K853686 — PRECEPT TM AMIKACIN (September 13, 1985)
  • K853688 — PRECEPT TM TOBRAMYCIN (September 13, 1985)
  • K853689 — PRECEPT TM MOXALACTAM (September 13, 1985)
  • K853687 — PRECEPT NETILMICIN 32-13 (September 13, 1985)
  • K853684 — PRECEPT KANAMYCIN (September 13, 1985)

FDA data resources