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FDA 510(k)

COLLOID OSMOMETER 4400

K-Number: K834208 · 1984-03-23

ApplicantWescor, Inc.
Decision Date1984-03-23
Product CodeJJM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COLLOID OSMOMETER 4400 is the device name listed in this FDA 510(k) record. The listed applicant is Wescor, Inc.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K834208. The device is classified under product code JJM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLOID OSMOMETER 4400?

COLLOID OSMOMETER 4400 is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Wescor, Inc.. The 510(k) number is K834208.

When did COLLOID OSMOMETER 4400 receive FDA 510(k) clearance?

COLLOID OSMOMETER 4400 received FDA 510(k) clearance on 1984-03-23, under 510(k) number K834208.

Who is the listed applicant for COLLOID OSMOMETER 4400?

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

What is the FDA product code for COLLOID OSMOMETER 4400?

The FDA product code for COLLOID OSMOMETER 4400 is JJM.

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Other records listing Wescor, 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.

K121823CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRICK010031NANODUCT NEONATAL SWEAT ANALYSIS SYSTEMK863395WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZERK881592WESCOR MODEL 7300 AEROSPRAY GRAM STAINERK881512WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAYK880544WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY

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Related Devices (Code: JJM)

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.

K965036THE ADVANCED OSMOMETER (3900)Advanced Instruments, Inc.K962056ADVANCED MICRO-OSMOMETER MODEL 3300Advanced Instruments, Inc.K925970MODEL 3D3 OSMOMETERAdvanced Instruments, Inc.K911092OSMOMETER MODEL 2400Advanced Instruments, Inc.K873642OSMOMETER MODEL 110Advanced Instruments, Inc.K843997AO-10 AUTOMATED OSMOMETERbioMerieux, 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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