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FDA 510(k)

HEMATOLOGY STAIN PACK

K-Number: K781587 · 1978-10-10

ApplicantBioscientific
Decision Date1978-10-10
Product CodeIAF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATOLOGY STAIN PACK is the device name listed in this FDA 510(k) record. The listed applicant is Bioscientific. It received FDA 510(k) clearance on 1978-10-10 under 510(k) number K781587. The device is classified under product code IAF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMATOLOGY STAIN PACK?

HEMATOLOGY STAIN PACK is a medical device that received FDA 510(k) clearance on 1978-10-10. The listed applicant is Bioscientific. The 510(k) number is K781587.

When did HEMATOLOGY STAIN PACK receive FDA 510(k) clearance?

HEMATOLOGY STAIN PACK received FDA 510(k) clearance on 1978-10-10, under 510(k) number K781587.

Who is the listed applicant for HEMATOLOGY STAIN PACK?

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

What is the FDA product code for HEMATOLOGY STAIN PACK?

The FDA product code for HEMATOLOGY STAIN PACK is IAF.

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Other records listing Bioscientific 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.

K812447AMYLASE REAGENT KITK811251CITRATE BUFFERK801268HEMOGLOBIN CONTROL LEVELSK801265WHITE BLOOD CELL COUNT CONTROL LEVELSK801267RED BLOOD CELL COUNT & HEMATOCRIT CNTLK791658WRIGHT STAIN PACK

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Related Devices (Code: IAF)

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.

K890674ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SETSigma Diagnostics, Inc.K890673WRIGHT-GLEMSA STAINSigma Diagnostics, Inc.K854236HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDSNms Pharmaceuticals, Inc.K860793CAMCO STAIN PAKCambridge Chemical Products, Inc.K853241HEMATOLOGY STAIN PACKFisher Scientific Co., LLCK852138WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE SCanyon Diagnostics, 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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