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510(k) K972406

ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM by Immunoprobe, Inc. — Product Code GOD

K972406 is an FDA 510(k) premarket notification submitted by Immunoprobe, Inc. for the device "ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on December 22, 1997. The device falls under product code GOD (Antigens, Cf (Including Cf Control), Adenovirus 1-33), a Class I device regulated under 21 CFR 866.3020. Immunoprobe, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1997
Date Received
June 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf (Including Cf Control), Adenovirus 1-33
Device Class
Class I
Regulation Number
866.3020
Review Panel
MI
Submission Type

Other clearances by Immunoprobe, Inc.

  • K971393 — MYCOPLASMA IGG ELISA TEST SYSTEM (July 14, 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)
  • K952523 — CARDIOLIPIN IGG EIA TEST KIT (February 9, 1996)
  • K952522 — CARDIOLIPIN IGA EIA TEST SYSTEM (February 9, 1996)
  • K952521 — CARDIOLIPIN IGM EIA TEST SYSTEM (February 9, 1996)
  • K951362 — THYROGLOBULIN EIA TEST KIT (November 20, 1995)
  • K951364 — MICROSOMAL EIA TEST KIT (November 20, 1995)
  • K951363 — CARDIOLIPIN IGG,M,A EIA TEST SYSTEM (October 13, 1995)

Other clearances for product code GOD

  • K110722 — RPS ADENO DETECTOR PLUS (May 17, 2011)
  • K052092 — RPS ADENO DETECTOR (November 22, 2005)
  • K990630 — SAS ADENO TEST (August 19, 1999)
  • K881894 — ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) (July 8, 1988)
  • K873082 — ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST (February 24, 1988)
  • K873312 — ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST (February 24, 1988)
  • K871229 — ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL (June 26, 1987)
  • K864645 — ADENOLEX (R) LATEX AGGLUTINATION TEST (June 4, 1987)
  • K843649 — ADENOVIRUS (September 26, 1985)
  • K802929 — ADENO VIRUS & CONTROLS (December 31, 1980)

FDA data resources