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FDA 510(k)

CELL-DYN RAPID-LYSE AND HEMOGLOBLIN

K-Number: K881242 · 1988-04-21

ApplicantAbbott Diagnostics
Decision Date1988-04-21
Product CodeGJZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN RAPID-LYSE AND HEMOGLOBLIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics. It received FDA 510(k) clearance on 1988-04-21 under 510(k) number K881242. The device is classified under product code GJZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELL-DYN RAPID-LYSE AND HEMOGLOBLIN?

CELL-DYN RAPID-LYSE AND HEMOGLOBLIN is a medical device that received FDA 510(k) clearance on 1988-04-21. The listed applicant is Abbott Diagnostics. The 510(k) number is K881242.

When did CELL-DYN RAPID-LYSE AND HEMOGLOBLIN receive FDA 510(k) clearance?

CELL-DYN RAPID-LYSE AND HEMOGLOBLIN received FDA 510(k) clearance on 1988-04-21, under 510(k) number K881242.

Who is the listed applicant for CELL-DYN RAPID-LYSE AND HEMOGLOBLIN?

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 RAPID-LYSE AND HEMOGLOBLIN?

The FDA product code for CELL-DYN RAPID-LYSE AND HEMOGLOBLIN is GJZ.

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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 ANALYERK881130CELL-DYN ISOTONIC DILUENTK873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.

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Related Devices (Code: GJZ)

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.

K883683HEMOGLOBINTech-Co, 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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