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FDA 510(k)

LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2

K-Number: K933317 · 1993-08-11

ApplicantBio-Rad
Decision Date1993-08-11
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1993-08-11 under 510(k) number K933317. 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 LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2?

LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 is a medical device that received FDA 510(k) clearance on 1993-08-11. The listed applicant is Bio-Rad. The 510(k) number is K933317.

When did LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 receive FDA 510(k) clearance?

LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 received FDA 510(k) clearance on 1993-08-11, under 510(k) number K933317.

Who is the listed applicant for LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2?

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

What is the FDA product code for LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2?

The FDA product code for LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 is JJY.

Related Clinical Trials

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.

Other records listing Bio-Rad 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: JJY)

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.

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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