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510(k) K872568

ROTASCREEN by Mercia Diagnostics , Ltd. — Product Code GOB

K872568 is an FDA 510(k) premarket notification submitted by Mercia Diagnostics , Ltd. for the device "ROTASCREEN". The FDA issued a decision of Substantially Equivalent on September 14, 1987. The device falls under product code GOB (Antigens, Ha (Including Ha Control), Adenovirus 1-33), a Class I device regulated under 21 CFR 866.3020. Mercia Diagnostics , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1987
Date Received
June 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Mercia Diagnostics , Ltd.

  • K915479 — CAPTIA CMV-TA (May 4, 1992)
  • K904524 — CAPTIA(R) SYPHILIS M, MODIFICATION (December 26, 1990)
  • K900654 — MODIFIED CAPTIA(R) SYPHILIS-M (March 8, 1990)
  • K896295 — CAPTIA(R) CMV-M (March 6, 1990)
  • K900655 — MODIFIED CAPTIA(R) TOXO-M (March 6, 1990)
  • K896194 — CAPTIA(R) CMV-G (March 6, 1990)
  • K883924 — CAPTIA(R) RUBELLA-G (August 15, 1989)
  • K885300 — CAPTIA(R) RUBELLA-M (August 15, 1989)
  • K892802 — SUPER DUO (June 13, 1989)
  • K881425 — CAPTIA(R) SYPHILIS-G (August 4, 1988)

FDA data resources