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FDA 510(k)

CARA-STAIN MODEL 3000

K-Number: K771699 · 1977-09-13

ApplicantAmerican Safety Equipment Corp.
Decision Date1977-09-13
Product CodeKPA
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

CARA-STAIN MODEL 3000 is the device name listed in this FDA 510(k) record. The listed applicant is American Safety Equipment Corp.. It received FDA 510(k) clearance on 1977-09-13 under 510(k) number K771699. 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 CARA-STAIN MODEL 3000?

CARA-STAIN MODEL 3000 is a medical device that received FDA 510(k) clearance on 1977-09-13. The listed applicant is American Safety Equipment Corp.. The 510(k) number is K771699.

When did CARA-STAIN MODEL 3000 receive FDA 510(k) clearance?

CARA-STAIN MODEL 3000 received FDA 510(k) clearance on 1977-09-13, under 510(k) number K771699.

Who is the listed applicant for CARA-STAIN MODEL 3000?

The FDA 510(k) record lists American Safety Equipment Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARA-STAIN MODEL 3000?

The FDA product code for CARA-STAIN MODEL 3000 is KPA. This falls under the Cardiovascular category.

Related Clinical Trials

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Other records listing American Safety Equipment Corp. 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.

K801010KIRSCHNER WIREK760960SURGICAL WIRE DRIVERK760956SURGICAL MICRO DRILLK760958SURGICAL OSCILLATING SAWK760959SURGICAL CHISELK760957SURGICAL RECIPROCATING SAW

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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.K881592WESCOR MODEL 7300 AEROSPRAY GRAM STAINERWescor, Inc.K880745LX-100 SLIDE STAINERInnovative Medical Systems, Inc.K874887WESBLOT PROCESSORAmerican Bionetics, Inc.K874897SAKURA DRS-60 AUTOMATIC SLIDE STAINERSakura Finetek U.S.A., 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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