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FDA 510(k)

LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

K-Number: K970778 · 1997-04-17

ApplicantMore Diagnostics
Decision Date1997-04-17
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 is the device name listed in this FDA 510(k) record. The listed applicant is More Diagnostics. It received FDA 510(k) clearance on 1997-04-17 under 510(k) number K970778. 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 LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4?

LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 is a medical device that received FDA 510(k) clearance on 1997-04-17. The listed applicant is More Diagnostics. The 510(k) number is K970778.

When did LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 receive FDA 510(k) clearance?

LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 received FDA 510(k) clearance on 1997-04-17, under 510(k) number K970778.

Who is the listed applicant for LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4?

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 LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4?

The FDA product code for LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 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-LEVELK946193FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3

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Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.

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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