Home / 510(k) Clearances / K920212

510(k) K920212

MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM by Shared Systems, Inc. — Product Code LJZ

K920212 is an FDA 510(k) premarket notification submitted by Shared Systems, Inc. for the device "MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on August 20, 1992. The device falls under product code LJZ (Enzyme Linked Immunoabsorbent Assay, 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
August 20, 1992
Date Received
January 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, 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)
  • K950073 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM (October 17, 1995)
  • K953261 — CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM (August 15, 1995)

Other clearances for product code LJZ

  • K984153 — THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. (January 11, 1999)
  • K971503 — MYCOPLASMA IGM ELISA TEST SYSTEM (August 20, 1997)
  • K971393 — MYCOPLASMA IGG ELISA TEST SYSTEM (July 14, 1997)
  • K970150 — MYCOPLASMA IGG ELISA TEST SYSTEM (June 16, 1997)
  • K963054 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) (May 5, 1997)
  • K963055 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 (May 2, 1997)
  • K934550 — IMMUNOCARD MYCOPLASMA (September 20, 1994)
  • K921556 — MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM (June 29, 1992)
  • K904501 — MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM (February 26, 1991)
  • K895276 — DIATECH IGM-MP TEST (December 18, 1989)

FDA data resources