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FDA 510(k)

GENOTROPIN MIXER

K-Number: K954337 · 1995-11-13

ApplicantPharmacia, Inc.
Decision Date1995-11-13
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GENOTROPIN MIXER is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1995-11-13 under 510(k) number K954337. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENOTROPIN MIXER?

GENOTROPIN MIXER is a medical device that received FDA 510(k) clearance on 1995-11-13. The listed applicant is Pharmacia, Inc.. The 510(k) number is K954337.

When did GENOTROPIN MIXER receive FDA 510(k) clearance?

GENOTROPIN MIXER received FDA 510(k) clearance on 1995-11-13, under 510(k) number K954337.

Who is the listed applicant for GENOTROPIN MIXER?

The FDA 510(k) record lists Pharmacia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENOTROPIN MIXER?

The FDA product code for GENOTROPIN MIXER is FMF.

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Other records listing Pharmacia, Inc. 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.

K974350ALLERGAN IMMUNO CAP M4, M8, K70K972364UNICAP PHADIATOPK972068UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82K970420MASTERCAP AM 5.0/MASTERCAP RM 5.0K964152UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMHK962274UNICAP 100

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Related Devices (Code: FMF)

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.

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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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