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FDA 510(k)

CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL

K-Number: K904781 · 1990-12-18

ApplicantCholestrech Corp.
Decision Date1990-12-18
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Cholestrech Corp.. It received FDA 510(k) clearance on 1990-12-18 under 510(k) number K904781. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL?

CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL is a medical device that received FDA 510(k) clearance on 1990-12-18. The listed applicant is Cholestrech Corp.. The 510(k) number is K904781.

When did CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL receive FDA 510(k) clearance?

CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL received FDA 510(k) clearance on 1990-12-18, under 510(k) number K904781.

Who is the listed applicant for CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL?

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

What is the FDA product code for CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL?

The FDA product code for CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL is JJY.

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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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