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FDA 510(k)

LANCER L-INA ANTI-IGG

K-Number: K791403 · 1979-10-17

ApplicantSherwood Medical Co.
Decision Date1979-10-17
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LANCER L-INA ANTI-IGG 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 1979-10-17 under 510(k) number K791403. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LANCER L-INA ANTI-IGG?

LANCER L-INA ANTI-IGG is a medical device that received FDA 510(k) clearance on 1979-10-17. The listed applicant is Sherwood Medical Co.. The 510(k) number is K791403.

When did LANCER L-INA ANTI-IGG receive FDA 510(k) clearance?

LANCER L-INA ANTI-IGG received FDA 510(k) clearance on 1979-10-17, under 510(k) number K791403.

Who is the listed applicant for LANCER L-INA ANTI-IGG?

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 L-INA ANTI-IGG?

The FDA product code for LANCER L-INA ANTI-IGG is DEW.

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Other records listing Sherwood Medical Co. as applicant

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Related Devices (Code: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

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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