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FDA 510(k)

CK/LD ISOENZYMES CONTROLS(HUMAN)

K-Number: K851520 · 1985-06-25

ApplicantSeragen Diagnostics, Inc.
Decision Date1985-06-25
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK/LD ISOENZYMES CONTROLS(HUMAN) is the device name listed in this FDA 510(k) record. The listed applicant is Seragen Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K851520. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK/LD ISOENZYMES CONTROLS(HUMAN)?

CK/LD ISOENZYMES CONTROLS(HUMAN) is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K851520.

When did CK/LD ISOENZYMES CONTROLS(HUMAN) receive FDA 510(k) clearance?

CK/LD ISOENZYMES CONTROLS(HUMAN) received FDA 510(k) clearance on 1985-06-25, under 510(k) number K851520.

Who is the listed applicant for CK/LD ISOENZYMES CONTROLS(HUMAN)?

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

What is the FDA product code for CK/LD ISOENZYMES CONTROLS(HUMAN)?

The FDA product code for CK/LD ISOENZYMES CONTROLS(HUMAN) is JJT.

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Other records listing Seragen 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: JJT)

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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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