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FDA 510(k)

SYS MACRODUCT SWEAT COLLECTION SYS 3600

K-Number: K840472 · 1984-03-19

ApplicantWescor, Inc.
Decision Date1984-03-19
Product CodeKTB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SYS MACRODUCT SWEAT COLLECTION SYS 3600 is the device name listed in this FDA 510(k) record. The listed applicant is Wescor, Inc.. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K840472. The device is classified under product code KTB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYS MACRODUCT SWEAT COLLECTION SYS 3600?

SYS MACRODUCT SWEAT COLLECTION SYS 3600 is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Wescor, Inc.. The 510(k) number is K840472.

When did SYS MACRODUCT SWEAT COLLECTION SYS 3600 receive FDA 510(k) clearance?

SYS MACRODUCT SWEAT COLLECTION SYS 3600 received FDA 510(k) clearance on 1984-03-19, under 510(k) number K840472.

Who is the listed applicant for SYS MACRODUCT SWEAT COLLECTION SYS 3600?

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 SYS MACRODUCT SWEAT COLLECTION SYS 3600?

The FDA product code for SYS MACRODUCT SWEAT COLLECTION SYS 3600 is KTB.

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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

View all 13 devices →

Related Devices (Code: KTB)

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.

K180627Macroduct Advanced Model 3710Elitechgroup, Inc.K033192RH-950Iomed, Inc.K031551NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)Vyteris, Inc.K031115RH-900Iomed, Inc.K010031NANODUCT NEONATAL SWEAT ANALYSIS SYSTEMWescor, Inc.K001522TRANSQ3Iomed, 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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