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510(k) K790671

DERMATOPHYTIN O by Diagnostica, Inc. — Product Code JXB

K790671 is an FDA 510(k) premarket notification submitted by Diagnostica, Inc. for the device "DERMATOPHYTIN O". The FDA issued a decision of Substantially Equivalent on May 31, 1979. The device falls under product code JXB (Kit, Identification, Yeast), a Class I device regulated under 21 CFR 866.2660. Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1979
Date Received
April 6, 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 Diagnostica, Inc.

  • K002756 — EASE-A-CULT (February 23, 2001)
  • K823348 — H. INFLUENZA B ANTISERA FOR CIE (December 28, 1982)
  • K812434 — DIAGNOSTIC KITS & KIT COMPONENTS (September 23, 1981)
  • K800398 — PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT (March 12, 1980)
  • K791284 — ANTI-HUMAN KAPPA SERUM (November 27, 1979)
  • K791283 — ANTI-HUMAN LAMBDA SERUM (November 27, 1979)
  • K791281 — ANTI-HUMAN IGG SERUM (November 27, 1979)
  • K791285 — ANTI-HUMAN GLOBULINS (October 17, 1979)
  • K791282 — ANTI-HUMAN SERUM (October 17, 1979)
  • K790672 — ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU (May 31, 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