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510(k) K000336

RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E by Rhigene, Inc. — Product Code NBO

K000336 is an FDA 510(k) premarket notification submitted by Rhigene, Inc. for the device "RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E". The FDA issued a decision of Substantially Equivalent on June 9, 2000. The device falls under product code NBO (Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)), a Class II device regulated under 21 CFR 866.5660. Rhigene, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2000
Date Received
February 3, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Rhigene, Inc.

  • K040711 — MESACUP TEST PR-3 (April 2, 2004)
  • K040586 — MESACUP TEST MPO, MODEL 11053 (March 22, 2004)
  • K040200 — MESACUP-2 TEST CENP-B (March 4, 2004)
  • K033528 — MESACUP-2 TEST JO-1, MODEL 10756 (December 22, 2003)
  • K031308 — RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 (September 26, 2003)
  • K022017 — RHIGENE MESACUP-2 TEST RNP, MODEL M7741 (August 14, 2002)
  • K022018 — RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 (July 5, 2002)
  • K011068 — RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L (April 11, 2002)
  • K000755 — RHIGENE MESACUP2 TEST- SM (May 9, 2000)
  • K000751 — RHIGENE MESACUP2 TEST- SSB (May 9, 2000)

Other clearances for product code NBO

  • K091969 — EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) (September 2, 2010)

FDA data resources