Home / 510(k) Clearances / K771008

510(k) K771008

API 20C by Analytical Products, Inc. — Product Code JXB

K771008 is an FDA 510(k) premarket notification submitted by Analytical Products, Inc. for the device "API 20C". The FDA issued a decision of Substantially Equivalent on August 3, 1977. The device falls under product code JXB (Kit, Identification, Yeast), a Class I device regulated under 21 CFR 866.2660. Analytical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1977
Date Received
June 3, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Yeast
Device Class
Class I
Regulation Number
866.2660
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 JXB

  • K080719 — YEAST TRAFFIC LIGHT PNA FISH (September 12, 2008)
  • K062461 — C. ALBICANS PNA FISH (October 25, 2006)
  • K993554 — YEASTEST (February 10, 2000)
  • K943621 — RAPID YEAST PLUS SYSTEM (January 27, 1995)
  • K935124 — BACTICARD CANDIDA (February 25, 1994)
  • K900112 — MICRORING YT (July 31, 1990)
  • K881925 — VITEK YEAST BIOCHEMICAL CARD (June 16, 1988)
  • K860575 — YEAST IDENTIFICATION PANEL (May 13, 1986)
  • K830286 — YEAST IDENT (April 5, 1983)
  • K802309 — MS-2 IDENTIFICATION SYSTEM (December 1, 1980)

FDA data resources