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510(k) K885113

IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL by Investigacion Farmaceutica S.A. DE C.V. — Product Code GSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1989
Date Received
December 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Positive And Negative Febrile Antigen Control Serum
Device Class
Class II
Regulation Number
866.3085
Review Panel
MI
Submission Type

Other clearances by Investigacion Farmaceutica S.A. DE C.V.

  • K892721 — IFA SENSIBAC CEFACLOR (November 30, 1989)
  • K892728 — IFA SENSIBAC NORFLOXACIN (September 21, 1989)
  • K892733 — IFA SENSIBAC KANAMYCIN (August 17, 1989)
  • K892713 — IFA SENSIBAC NALIDIXIC ACID (August 17, 1989)
  • K892735 — IFA SENSIBAC CEPHALOTIN (August 17, 1989)
  • K885110 — PROTEUS OX-19 IFA* (August 15, 1989)
  • K885114 — SALMONELLA IFA* (August 15, 1989)
  • K892726 — IFA SENSIBAC PENICILLIN (August 15, 1989)
  • K885112 — BRUCELLA IFA* (August 15, 1989)
  • K892720 — IFA SENSIBAC GENTAMYCIN (August 15, 1989)

Other clearances for product code GSN

  • K952145 — SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM (July 18, 1995)
  • K791385 — NEGATIVE CONTROL SERUM FOR CF RO ID (August 16, 1979)