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FDA 510(k)

THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES

K-Number: K973203 · 1998-09-30

ApplicantSangstat Medical Corp.
Decision Date1998-09-30
Product CodeDAK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Sangstat Medical Corp.. It received FDA 510(k) clearance on 1998-09-30 under 510(k) number K973203. The device is classified under product code DAK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES?

THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES is a medical device that received FDA 510(k) clearance on 1998-09-30. The listed applicant is Sangstat Medical Corp.. The 510(k) number is K973203.

When did THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES receive FDA 510(k) clearance?

THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES received FDA 510(k) clearance on 1998-09-30, under 510(k) number K973203.

Who is the listed applicant for THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES?

The FDA 510(k) record lists Sangstat Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES?

The FDA product code for THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES is DAK.

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Other records listing Sangstat Medical Corp. 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.

K991594CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTSK980109CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER

Related Devices (Code: DAK)

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.

K031563BINDAZYME CLQ CIC EIA KITThe Binding Site, Ltd.K032254IBL C1Q-CIC CIA TESTIbl GmbHK012576CIC-C1Q EIAAmerican Laboratory Products Co., Ltd.K972873IMMUSTRIP HAMA IGGImmunomedics, Inc.K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.K914388C1 RID KITThe Binding Site, Ltd.

Official Source

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

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