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FDA 510(k)

LANCER CREATININE MICROSAMPLE STAT ANA

K-Number: K803087 · 1981-01-02

ApplicantSherwood Medical Co.
Decision Date1981-01-02
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LANCER CREATININE MICROSAMPLE STAT ANA is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1981-01-02 under 510(k) number K803087. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LANCER CREATININE MICROSAMPLE STAT ANA?

LANCER CREATININE MICROSAMPLE STAT ANA is a medical device that received FDA 510(k) clearance on 1981-01-02. The listed applicant is Sherwood Medical Co.. The 510(k) number is K803087.

When did LANCER CREATININE MICROSAMPLE STAT ANA receive FDA 510(k) clearance?

LANCER CREATININE MICROSAMPLE STAT ANA received FDA 510(k) clearance on 1981-01-02, under 510(k) number K803087.

Who is the listed applicant for LANCER CREATININE MICROSAMPLE STAT ANA?

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

What is the FDA product code for LANCER CREATININE MICROSAMPLE STAT ANA?

The FDA product code for LANCER CREATININE MICROSAMPLE STAT ANA is CGX.

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Other records listing Sherwood Medical Co. as applicant

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Related Devices (Code: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, 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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