Home / 510(k) Clearances / K881894

510(k) K881894

ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) by Cambridge Bioscience Corp. — Product Code GOD

K881894 is an FDA 510(k) premarket notification submitted by Cambridge Bioscience Corp. for the device "ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)". The FDA issued a decision of Substantially Equivalent on July 8, 1988. 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. Cambridge Bioscience Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1988
Date Received
May 5, 1988
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 Cambridge Bioscience Corp.

  • K890281 — HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES (March 15, 1989)
  • K873082 — ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST (February 24, 1988)
  • K873312 — ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST (February 24, 1988)
  • K852969 — ROTACLONE ROTAVIRUS DIAGNOSTIC KIT (November 5, 1985)

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)
  • K972406 — ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM (December 22, 1997)
  • K873312 — ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST (February 24, 1988)
  • K873082 — ADENOCLONE(TM)-EIA 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