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510(k) K052092

RPS ADENO DETECTOR by Rapid Pathogen Screening — Product Code GOD

K052092 is an FDA 510(k) premarket notification submitted by Rapid Pathogen Screening for the device "RPS ADENO DETECTOR". The FDA issued a decision of Substantially Equivalent on November 22, 2005. 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. Rapid Pathogen Screening has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2005
Date Received
August 2, 2005
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 Rapid Pathogen Screening

  • K132066 — INFLAMMA DRY (November 21, 2013)
  • K110722 — RPS ADENO DETECTOR PLUS (May 17, 2011)

Other clearances for product code GOD

  • K110722 — RPS ADENO DETECTOR PLUS (May 17, 2011)
  • 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)
  • 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