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FDA 510(k)

PHALDEBAS DIGOXIN RIA

K-Number: K770322 · 1977-04-05

ApplicantPharmacia, Inc.
Decision Date1977-04-05
Product CodeLCS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PHALDEBAS DIGOXIN RIA is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1977-04-05 under 510(k) number K770322. The device is classified under product code LCS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHALDEBAS DIGOXIN RIA?

PHALDEBAS DIGOXIN RIA is a medical device that received FDA 510(k) clearance on 1977-04-05. The listed applicant is Pharmacia, Inc.. The 510(k) number is K770322.

When did PHALDEBAS DIGOXIN RIA receive FDA 510(k) clearance?

PHALDEBAS DIGOXIN RIA received FDA 510(k) clearance on 1977-04-05, under 510(k) number K770322.

Who is the listed applicant for PHALDEBAS DIGOXIN RIA?

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 PHALDEBAS DIGOXIN RIA?

The FDA product code for PHALDEBAS DIGOXIN RIA is LCS.

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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: LCS)

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.

K922353DIGOXIN COATED TUBE RIAMonobindK913562QMS - DIGOXINSeradyn, Inc.K895828INNOFLUOR DIGOXIN REAGENT SETInnotron of Oregon, Inc.K884707FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KITCyberfluor, Inc.K874748IMMPULSE DIGOXIN ASSAY REAGENTSSclavo, Inc.K864802DART DIGOXIN ASSAYCoulter Electronics, 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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