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FDA 510(k)

LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2

K-Number: K932660 · 1993-10-28

ApplicantMore Diagnostics
Decision Date1993-10-28
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 is the device name listed in this FDA 510(k) record. The listed applicant is More Diagnostics. It received FDA 510(k) clearance on 1993-10-28 under 510(k) number K932660. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2?

LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 is a medical device that received FDA 510(k) clearance on 1993-10-28. The listed applicant is More Diagnostics. The 510(k) number is K932660.

When did LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 receive FDA 510(k) clearance?

LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 received FDA 510(k) clearance on 1993-10-28, under 510(k) number K932660.

Who is the listed applicant for LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2?

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

What is the FDA product code for LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2?

The FDA product code for LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 is JJX.

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Other records listing More Diagnostics 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.

K072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELK050125RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4K982845CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3K980331IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\SK972976CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVELK970778LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

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Related Devices (Code: JJX)

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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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