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FDA 510(k)

LD-1 CONTROL-LEVEL 1 & 2

K-Number: K930874 · 1993-04-22

ApplicantCala Diagnostics
Decision Date1993-04-22
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LD-1 CONTROL-LEVEL 1 & 2 is the device name listed in this FDA 510(k) record. The listed applicant is Cala Diagnostics. It received FDA 510(k) clearance on 1993-04-22 under 510(k) number K930874. 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 CONTROL-LEVEL 1 & 2?

LD-1 CONTROL-LEVEL 1 & 2 is a medical device that received FDA 510(k) clearance on 1993-04-22. The listed applicant is Cala Diagnostics. The 510(k) number is K930874.

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

LD-1 CONTROL-LEVEL 1 & 2 received FDA 510(k) clearance on 1993-04-22, under 510(k) number K930874.

Who is the listed applicant for LD-1 CONTROL-LEVEL 1 & 2?

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

What is the FDA product code for LD-1 CONTROL-LEVEL 1 & 2?

The FDA product code for LD-1 CONTROL-LEVEL 1 & 2 is JJX.

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Other records listing Cala 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.

K944246CARDIOCHEX CKMB MASS MEASUREMENT CONTROLK944247CARDIOCHEX CKMB IMMUNOINHIBITION CONTROLK944243CARDIOCHEXK930873CKMB ISOENZYME CONTROL-LEVEL 1,2.3K930875CKMB CONTROL - LEVEL 1,2,3K926015CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 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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