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510(k) K971393

MYCOPLASMA IGG ELISA TEST SYSTEM by Immunoprobe, Inc. — Product Code LJZ

K971393 is an FDA 510(k) premarket notification submitted by Immunoprobe, Inc. for the device "MYCOPLASMA IGG ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 14, 1997. The device falls under product code LJZ (Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Immunoprobe, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1997
Date Received
April 9, 1997
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 Immunoprobe, Inc.

  • K972406 — ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM (December 22, 1997)
  • K961764 — PR-3 ELISA TEST SYSTEM (August 19, 1996)
  • K961765 — MPO ELISA TEST SYSTEM (August 19, 1996)
  • K951549 — EBNA IGG EIA TEST SYSTEM (April 29, 1996)
  • K952521 — CARDIOLIPIN IGM EIA TEST SYSTEM (February 9, 1996)
  • K952523 — CARDIOLIPIN IGG EIA TEST KIT (February 9, 1996)
  • K952522 — CARDIOLIPIN IGA EIA TEST SYSTEM (February 9, 1996)
  • K951364 — MICROSOMAL EIA TEST KIT (November 20, 1995)
  • K951362 — THYROGLOBULIN EIA TEST KIT (November 20, 1995)
  • K951363 — CARDIOLIPIN IGG,M,A EIA TEST SYSTEM (October 13, 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)
  • 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)
  • K920212 — MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM (August 20, 1992)
  • 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