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FDA 510(k)

BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA

K-Number: K850970 · 1985-03-29

ApplicantGranite Diagnostics, Inc.
Decision Date1985-03-29
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA is the device name listed in this FDA 510(k) record. The listed applicant is Granite Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-03-29 under 510(k) number K850970. The device is classified under product code JSJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA?

BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA is a medical device that received FDA 510(k) clearance on 1985-03-29. The listed applicant is Granite Diagnostics, Inc.. The 510(k) number is K850970.

When did BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA receive FDA 510(k) clearance?

BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA received FDA 510(k) clearance on 1985-03-29, under 510(k) number K850970.

Who is the listed applicant for BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA?

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

What is the FDA product code for BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA?

The FDA product code for BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA is JSJ.

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Other records listing Granite Diagnostics, 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.

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Related Devices (Code: JSJ)

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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