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510(k) K802934

MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL by Orion Diagnostica, Inc. — Product Code GSB

K802934 is an FDA 510(k) premarket notification submitted by Orion Diagnostica, Inc. for the device "MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL". The FDA issued a decision of Substantially Equivalent on December 31, 1980. The device falls under product code GSB (Antigens, Cf, All, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Orion Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1980
Date Received
November 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf, All, Mycoplasma Spp.
Device Class
Class I
Regulation Number
866.3375
Review Panel
MI
Submission Type

Other clearances by Orion Diagnostica, Inc.

  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K043125 — ORION DIAGNOSTICA UNIQ PINP RIA (May 4, 2005)
  • K042625 — QUIKREAD CRP CALIBRATOR SET (November 18, 2004)
  • K042442 — QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODE (September 24, 2004)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K914892 — SALIVA-STIM (September 2, 1992)
  • K904655 — PYLORISET (October 21, 1991)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (October 19, 1988)

Other clearances for product code GSB

  • K852933 — MYCOPLASMA SPP SEROLOGICAL REAGENTS (August 1, 1985)
  • K843664 — MYCOPLASMA PNEUMONIAE (October 25, 1984)
  • K834338 — MYCOPLASMA PNEUMONIAE CF ANTIGEN (February 27, 1984)
  • K832132 — SERA-TEK MYCOPLASMA ANTIBODY TEST (September 20, 1983)

FDA data resources