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FDA 510(k)

IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL

K-Number: K885113 · 1989-08-15

ApplicantInvestigacion Farmaceutica S.A. DE C.V.
Decision Date1989-08-15
Product CodeGSN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Investigacion Farmaceutica S.A. DE C.V.. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K885113. The device is classified under product code GSN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL?

IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Investigacion Farmaceutica S.A. DE C.V.. The 510(k) number is K885113.

When did IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL receive FDA 510(k) clearance?

IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL received FDA 510(k) clearance on 1989-08-15, under 510(k) number K885113.

Who is the listed applicant for IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL?

The FDA 510(k) record lists Investigacion Farmaceutica S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL?

The FDA product code for IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL is GSN.

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Other records listing Investigacion Farmaceutica S.A. DE C.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K892721IFA SENSIBAC CEFACLORK892728IFA SENSIBAC NORFLOXACINK892733IFA SENSIBAC KANAMYCINK892713IFA SENSIBAC NALIDIXIC ACIDK892735IFA SENSIBAC CEPHALOTINK885110PROTEUS OX-19 IFA*

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Related Devices (Code: GSN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K952145SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUMSa Scientific, Inc.K791385NEGATIVE CONTROL SERUM FOR CF RO IDImmuno-Mycologics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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