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510(k) K950073

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM by Shared Systems, Inc. — Product Code GSA

K950073 is an FDA 510(k) premarket notification submitted by Shared Systems, Inc. for the device "MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on October 17, 1995. The device falls under product code GSA (Antisera, All Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Shared Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1995
Date Received
January 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Shared Systems, Inc.

  • K973457 — CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 (January 2, 1998)
  • K955042 — CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM (December 13, 1995)
  • K953261 — CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM (August 15, 1995)
  • K920212 — MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM (August 20, 1992)

Other clearances for product code GSA

  • K910833 — COLOR VUE TM- MYCOPLASMA PNEUMONIAE (June 24, 1991)
  • K905493 — MERISTAR-MP (January 30, 1991)
  • K903958 — SEROFAST (December 21, 1990)
  • K883083 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (October 25, 1988)
  • K862630 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (September 3, 1986)

FDA data resources