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FDA 510(k)

ULTRA-DIG

K-Number: K812749 · 1981-10-19

ApplicantAntibodies, Inc.
Decision Date1981-10-19
Product CodeLCS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ULTRA-DIG is the device name listed in this FDA 510(k) record. The listed applicant is Antibodies, Inc.. It received FDA 510(k) clearance on 1981-10-19 under 510(k) number K812749. 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 ULTRA-DIG?

ULTRA-DIG is a medical device that received FDA 510(k) clearance on 1981-10-19. The listed applicant is Antibodies, Inc.. The 510(k) number is K812749.

When did ULTRA-DIG receive FDA 510(k) clearance?

ULTRA-DIG received FDA 510(k) clearance on 1981-10-19, under 510(k) number K812749.

Who is the listed applicant for ULTRA-DIG?

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

What is the FDA product code for ULTRA-DIG?

The FDA product code for ULTRA-DIG is LCS.

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Other records listing Antibodies, 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.

K890774GIARDEIA(TM)K843590DETECT-A-STREPK822892CORTISOL RIA KITK812314CRITHIDNA ANTI-DNA TEST KITK802877AMIKACIN RIA KITK800743TOBRAMYCIN RIA KIT

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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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