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510(k) K790991

YEAST-PALETTE TM by Micro-Palettes, Inc. — Product Code JXB

K790991 is an FDA 510(k) premarket notification submitted by Micro-Palettes, Inc. for the device "YEAST-PALETTE TM". The FDA issued a decision of Substantially Equivalent on June 22, 1979. The device falls under product code JXB (Kit, Identification, Yeast), a Class I device regulated under 21 CFR 866.2660. Micro-Palettes, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1979
Date Received
May 29, 1979
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 Micro-Palettes, Inc.

  • K790992 — PSEUDO-PALETTE TM (June 22, 1979)

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