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510(k) K843649

ADENOVIRUS by Institute Virion , Ltd. — Product Code GOD

K843649 is an FDA 510(k) premarket notification submitted by Institute Virion , Ltd. for the device "ADENOVIRUS". The FDA issued a decision of Substantially Equivalent on September 26, 1985. 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. Institute Virion , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1985
Date Received
September 17, 1984
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 Institute Virion , Ltd.

  • K862814 — COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI (September 30, 1986)
  • K843665 — PARAINFLUENZA 1 (September 26, 1985)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K843673 — RESPIRATORY SYNCYTIAL VIRUS (September 26, 1985)
  • K843657 — CYTOMEGALOVIRUS (September 26, 1985)
  • K843660 — IN FLUENZA B VIRUS (September 26, 1985)
  • K843658 — H. SIMPLEX VIRUS (September 26, 1985)
  • K843676 — VARICELLA/ZOSTER VIRUS (September 26, 1985)
  • K843662 — MEASLES VIRUS RUBEOLA (September 26, 1985)
  • K843659 — INFLUENZA A2 VIRUS (September 26, 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)
  • K881894 — ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) (July 8, 1988)
  • 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)
  • K802929 — ADENO VIRUS & CONTROLS (December 31, 1980)

FDA data resources