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FDA 510(k)

BIO-DYES FORTIFIED HEMATOLOGY STAIN

K-Number: K770074 · 1977-03-22

ApplicantJack W. Kindberg
Decision Date1977-03-22
Product CodeIAF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIO-DYES FORTIFIED HEMATOLOGY STAIN is the device name listed in this FDA 510(k) record. The listed applicant is Jack W. Kindberg. It received FDA 510(k) clearance on 1977-03-22 under 510(k) number K770074. 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 BIO-DYES FORTIFIED HEMATOLOGY STAIN?

BIO-DYES FORTIFIED HEMATOLOGY STAIN is a medical device that received FDA 510(k) clearance on 1977-03-22. The listed applicant is Jack W. Kindberg. The 510(k) number is K770074.

When did BIO-DYES FORTIFIED HEMATOLOGY STAIN receive FDA 510(k) clearance?

BIO-DYES FORTIFIED HEMATOLOGY STAIN received FDA 510(k) clearance on 1977-03-22, under 510(k) number K770074.

Who is the listed applicant for BIO-DYES FORTIFIED HEMATOLOGY STAIN?

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

What is the FDA product code for BIO-DYES FORTIFIED HEMATOLOGY STAIN?

The FDA product code for BIO-DYES FORTIFIED HEMATOLOGY STAIN is IAF.

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 Jack W. Kindberg 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.

K770076BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACKK770075BIO-DYES HEMATOLOGY PHOSPHATE

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.

K890673WRIGHT-GLEMSA STAINSigma Diagnostics, Inc.K890674ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SETSigma 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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