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FDA 510(k)

HEMA-TEK II SLIDE STAINER

K-Number: K771559 · 1977-08-25

ApplicantMiles Laboratories, Inc.
Decision Date1977-08-25
Product CodeKPA
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

HEMA-TEK II SLIDE STAINER is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1977-08-25 under 510(k) number K771559. 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 HEMA-TEK II SLIDE STAINER?

HEMA-TEK II SLIDE STAINER is a medical device that received FDA 510(k) clearance on 1977-08-25. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K771559.

When did HEMA-TEK II SLIDE STAINER receive FDA 510(k) clearance?

HEMA-TEK II SLIDE STAINER received FDA 510(k) clearance on 1977-08-25, under 510(k) number K771559.

Who is the listed applicant for HEMA-TEK II SLIDE STAINER?

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

What is the FDA product code for HEMA-TEK II SLIDE STAINER?

The FDA product code for HEMA-TEK II SLIDE STAINER is KPA. This falls under the Cardiovascular category.

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Other records listing Miles Laboratories, Inc. as applicant

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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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