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FDA 510(k)

CELL-DYN BRAND HEMATOLOGY REAGENTS

K-Number: K852372 · 1985-09-03

ApplicantAbbott Diagnostics
Decision Date1985-09-03
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN BRAND HEMATOLOGY REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics. It received FDA 510(k) clearance on 1985-09-03 under 510(k) number K852372. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELL-DYN BRAND HEMATOLOGY REAGENTS?

CELL-DYN BRAND HEMATOLOGY REAGENTS is a medical device that received FDA 510(k) clearance on 1985-09-03. The listed applicant is Abbott Diagnostics. The 510(k) number is K852372.

When did CELL-DYN BRAND HEMATOLOGY REAGENTS receive FDA 510(k) clearance?

CELL-DYN BRAND HEMATOLOGY REAGENTS received FDA 510(k) clearance on 1985-09-03, under 510(k) number K852372.

Who is the listed applicant for CELL-DYN BRAND HEMATOLOGY REAGENTS?

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

What is the FDA product code for CELL-DYN BRAND HEMATOLOGY REAGENTS?

The FDA product code for CELL-DYN BRAND HEMATOLOGY REAGENTS is JPK.

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Other records listing Abbott Diagnostics 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.

K964185IMX CA 125K972182ABBOTT STREP A CONTROLSK961439ABBOTT CELL-DYN 4000 SYSTEMK890491CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYERK881242CELL-DYN RAPID-LYSE AND HEMOGLOBLINK881130CELL-DYN ISOTONIC DILUENT

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Related Devices (Code: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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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