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FDA 510(k)

HEMACAL

K-Number: K831306 · 1983-06-16

ApplicantHematology Marketing Assoc.
Decision Date1983-06-16
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMACAL is the device name listed in this FDA 510(k) record. The listed applicant is Hematology Marketing Assoc.. It received FDA 510(k) clearance on 1983-06-16 under 510(k) number K831306. The device is classified under product code KRZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMACAL?

HEMACAL is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Hematology Marketing Assoc.. The 510(k) number is K831306.

When did HEMACAL receive FDA 510(k) clearance?

HEMACAL received FDA 510(k) clearance on 1983-06-16, under 510(k) number K831306.

Who is the listed applicant for HEMACAL?

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

What is the FDA product code for HEMACAL?

The FDA product code for HEMACAL is KRZ.

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Other records listing Hematology Marketing Assoc. 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.

K851843OSMOCEL 3K851375TRI-COUNTK850097LASER-LYSEK850096LASER-GLOBINK850095LASER-DILK850094LASER-GLOBIN POWDER

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Related Devices (Code: KRZ)

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.

K052101C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1CRoche DiagnosticsK041130CDS HEMATOLOGY CALIBRATOR (CDS CAL)Clinical Diagnostic Solutions, Inc.K962864THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSAlko Diagnostic Corp.K951071ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERSAlko Diagnostic Corp.K902892CELL-DYN CALIBRATORUnipath , Ltd.K896921RAICHEM TM HEMOGLOBIN CALIBRATORReagents Applications, 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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