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FDA 510(k)

CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS

K-Number: K850157 · 1985-02-27

ApplicantShaban Mfg. Co.
Decision Date1985-02-27
Product CodeKPA
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS is the device name listed in this FDA 510(k) record. The listed applicant is Shaban Mfg. Co.. It received FDA 510(k) clearance on 1985-02-27 under 510(k) number K850157. 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 CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS?

CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS is a medical device that received FDA 510(k) clearance on 1985-02-27. The listed applicant is Shaban Mfg. Co.. The 510(k) number is K850157.

When did CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS receive FDA 510(k) clearance?

CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS received FDA 510(k) clearance on 1985-02-27, under 510(k) number K850157.

Who is the listed applicant for CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS?

The FDA 510(k) record lists Shaban Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS?

The FDA product code for CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS 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 Shaban Mfg. Co. 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.

K853621REPLACEMENT PUMP TUBINGK850333PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERSK844781MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LABK844235CHLORIDE STANDARDK842656REPLACEMENT PARTS NOVA ELECTROLYTE ANALK841610COMPONENTS FOR POTASSIUM, SODIUM CHLO

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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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