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510(k) K924814

API 20E/UNISCEPT 20E by Analytical Products, Inc. — Product Code JSS

K924814 is an FDA 510(k) premarket notification submitted by Analytical Products, Inc. for the device "API 20E/UNISCEPT 20E". The FDA issued a decision of Substantially Equivalent on Mar 11, 1993. The device falls under product code JSS (Kit, Identification, Enterobacteriaceae), a Class I device regulated under 21 CFR 866.2660. Analytical Products, Inc. has 56 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 11, 1993
Date Received
Sep 25, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Kit, Identification, Enterobacteriaceae
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type
510(k) Exempt

Other clearances by Analytical Products, Inc.

  • K923684 — API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC (Dec 3, 1992)
  • K922926 — API UNISCEPT KB/TYPE 2 AND 3 (Oct 13, 1992)
  • K901559 — MODIFICATION TO API UNISCEPT 20GP (Sep 10, 1990)
  • K901390 — DMAC INDOLE REAGENT (Apr 16, 1990)
  • K895796 — API UNISCEPT KB (Nov 13, 1989)
  • K884510 — MODIFICATION MICRO-MIC (Nov 22, 1988)
  • K884509 — MODIFICATION MIC/API UNISCEPT(R) (Nov 22, 1988)
  • K880598 — MODIFICATIONS TO API UNISCEPT (R) KB (Mar 23, 1988)
  • K874466 — API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC (Dec 9, 1987)
  • K865062 — ALADIN (TM) (Mar 25, 1987)

Other clearances for product code JSS

  • K150031 — hemoFISH Masterpanel (Oct 1, 2015)
  • K123418 — GRAM-NEGATIVE QUICKFISH BC (Jul 21, 2013)
  • K101558 — GNR TRAFFIC LIGHT PNA FISH (Dec 16, 2010)
  • K092236 — E.COLI/P. AERUGINOSA PNA FISH (Dec 16, 2009)
  • K092393 — EK/P. AERUGINOSA PNA FISH (Sep 1, 2009)
  • K082068 — E. COLI PNA FISH (Jun 25, 2009)
  • K081433 — EK/P. AERUGINOSA PNA FISH (Mar 26, 2009)
  • K081309 — E.COLI/P. AERUGINOSA PNA FISH (Dec 19, 2008)
  • K926002 — ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (Sep 23, 1993)
  • K926017 — CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM (Mar 11, 1993)

FDA data resources

Source: FDA 510(k) database entry for K924814. Report a data issue: hello@regdatalab.com.