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FDA 510(k)

IMMPULSE DIGOXIN ASSAY REAGENTS

K-Number: K874748 · 1988-02-19

ApplicantSclavo, Inc.
Decision Date1988-02-19
Product CodeLCS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMPULSE DIGOXIN ASSAY REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1988-02-19 under 510(k) number K874748. 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 IMMPULSE DIGOXIN ASSAY REAGENTS?

IMMPULSE DIGOXIN ASSAY REAGENTS is a medical device that received FDA 510(k) clearance on 1988-02-19. The listed applicant is Sclavo, Inc.. The 510(k) number is K874748.

When did IMMPULSE DIGOXIN ASSAY REAGENTS receive FDA 510(k) clearance?

IMMPULSE DIGOXIN ASSAY REAGENTS received FDA 510(k) clearance on 1988-02-19, under 510(k) number K874748.

Who is the listed applicant for IMMPULSE DIGOXIN ASSAY REAGENTS?

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

What is the FDA product code for IMMPULSE DIGOXIN ASSAY REAGENTS?

The FDA product code for IMMPULSE DIGOXIN ASSAY REAGENTS is LCS.

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Other records listing Sclavo, Inc. as applicant

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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.K864802DART DIGOXIN ASSAYCoulter Electronics, Inc.K820154TDX DIGOXINAbbott Laboratories

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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