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FDA 510(k)

LYTENING 1

K-Number: K853832 · 1985-10-04

ApplicantAmdev, Inc.
Decision Date1985-10-04
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYTENING 1 is the device name listed in this FDA 510(k) record. The listed applicant is Amdev, Inc.. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853832. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYTENING 1?

LYTENING 1 is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Amdev, Inc.. The 510(k) number is K853832.

When did LYTENING 1 receive FDA 510(k) clearance?

LYTENING 1 received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853832.

Who is the listed applicant for LYTENING 1?

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

What is the FDA product code for LYTENING 1?

The FDA product code for LYTENING 1 is JGS.

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Other records listing Amdev, Inc. 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.

K904726LYTENING TM 6/RK890524APEC GLUCOSE ANALYZERK884731LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZK880917LYTENING 5K863521LYTENING 2

Related Devices (Code: JGS)

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.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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