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FDA 510(k)

ACCESS CK-MB REAGENTS

K-Number: K945083 · 1994-11-21

ApplicantBio-Rad Laboratories, Inc.
Decision Date1994-11-21
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS CK-MB REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 1994-11-21 under 510(k) number K945083. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS CK-MB REAGENTS?

ACCESS CK-MB REAGENTS is a medical device that received FDA 510(k) clearance on 1994-11-21. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K945083.

When did ACCESS CK-MB REAGENTS receive FDA 510(k) clearance?

ACCESS CK-MB REAGENTS received FDA 510(k) clearance on 1994-11-21, under 510(k) number K945083.

Who is the listed applicant for ACCESS CK-MB REAGENTS?

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

What is the FDA product code for ACCESS CK-MB REAGENTS?

The FDA product code for ACCESS CK-MB REAGENTS is JHS.

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Related Devices (Code: JHS)

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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