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FDA 510(k)

HEMATOLOGY PAK

K-Number: K831605 · 1983-06-30

ApplicantMercedes Scientific Co., Inc.
Decision Date1983-06-30
Product CodeIAF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATOLOGY PAK is the device name listed in this FDA 510(k) record. The listed applicant is Mercedes Scientific Co., Inc.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831605. 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 PAK?

HEMATOLOGY PAK is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Mercedes Scientific Co., Inc.. The 510(k) number is K831605.

When did HEMATOLOGY PAK receive FDA 510(k) clearance?

HEMATOLOGY PAK received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831605.

Who is the listed applicant for HEMATOLOGY PAK?

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

What is the FDA product code for HEMATOLOGY PAK?

The FDA product code for HEMATOLOGY PAK 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 Mercedes Scientific Co., Inc. 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.

K830127QUIK-DIP BLOOD STAIN

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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