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FDA 510(k)

CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.

K-Number: K873348 · 1987-09-09

ApplicantAbbott Diagnostics
Decision Date1987-09-09
Product CodeGGK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics. It received FDA 510(k) clearance on 1987-09-09 under 510(k) number K873348. The device is classified under product code GGK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.?

CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. is a medical device that received FDA 510(k) clearance on 1987-09-09. The listed applicant is Abbott Diagnostics. The 510(k) number is K873348.

When did CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. receive FDA 510(k) clearance?

CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. received FDA 510(k) clearance on 1987-09-09, under 510(k) number K873348.

Who is the listed applicant for CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.?

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 DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.?

The FDA product code for CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. is GGK.

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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: GGK)

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.

K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IICoulter ImmunologyK883991KVM HEMOGLOBIN LYSING REAGENTKvm Technologies, Inc.K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTFisher Scientific Co., LLCK863114PIASTRINITJ. D. Assoc.K863503HEMOLYSEReagent Laboratory, Inc.K850097LASER-LYSEHematology Marketing Assoc.

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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