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FDA 510(k)

WESCOR MODEL 7300 AEROSPRAY GRAM STAINER

K-Number: K881592 · 1988-05-13

ApplicantWescor, Inc.
Decision Date1988-05-13
Product CodeKPA
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

WESCOR MODEL 7300 AEROSPRAY GRAM STAINER is the device name listed in this FDA 510(k) record. The listed applicant is Wescor, Inc.. It received FDA 510(k) clearance on 1988-05-13 under 510(k) number K881592. The device is classified under product code KPA. It was reviewed by the PA advisory panel. Product code KPA falls under the category of Cardiovascular, which encompasses devices for cardiovascular diagnosis, monitoring, and intervention. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WESCOR MODEL 7300 AEROSPRAY GRAM STAINER?

WESCOR MODEL 7300 AEROSPRAY GRAM STAINER is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Wescor, Inc.. The 510(k) number is K881592.

When did WESCOR MODEL 7300 AEROSPRAY GRAM STAINER receive FDA 510(k) clearance?

WESCOR MODEL 7300 AEROSPRAY GRAM STAINER received FDA 510(k) clearance on 1988-05-13, under 510(k) number K881592.

Who is the listed applicant for WESCOR MODEL 7300 AEROSPRAY GRAM STAINER?

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 WESCOR MODEL 7300 AEROSPRAY GRAM STAINER?

The FDA product code for WESCOR MODEL 7300 AEROSPRAY GRAM STAINER is KPA. This falls under the Cardiovascular category.

Related Clinical Trials

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.

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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 ANALYZERK881512WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAYK880544WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAYK853973WESCOR MODEL 3700 WEBSTER SWEAT INDUCER

View all 13 devices →

Related Devices (Code: KPA)

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.

K933996PROFIBLOTTecan U.S., Ltd.K884258VERSABLOTAmerican Bionetics, Inc.K880745LX-100 SLIDE STAINERInnovative Medical Systems, Inc.K874887WESBLOT PROCESSORAmerican Bionetics, Inc.K874897SAKURA DRS-60 AUTOMATIC SLIDE STAINERSakura Finetek U.S.A., Inc.K872916HISTOMATIC SLIDE STAINER, CODE-ON VERSIONFisher Scientific Co., LLC

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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