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FDA 510(k)

HEMATOLOGY STAIN PACK

K-Number: K853241 · 1985-08-19

ApplicantFisher Scientific Co., LLC
Decision Date1985-08-19
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 Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1985-08-19 under 510(k) number K853241. 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 1985-08-19. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K853241.

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

HEMATOLOGY STAIN PACK received FDA 510(k) clearance on 1985-08-19, under 510(k) number K853241.

Who is the listed applicant for HEMATOLOGY STAIN PACK?

The FDA 510(k) record lists Fisher Scientific Co., LLC 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 Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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.

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.K852138WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE SCanyon Diagnostics, Inc.K842744WRIGHT STAINE K Ind., 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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