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FDA 510(k)

HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL

K-Number: K893895 · 1989-07-25

ApplicantIntercare Diagnostics, Inc.
Decision Date1989-07-25
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Intercare Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-07-25 under 510(k) number K893895. 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 HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL?

HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is Intercare Diagnostics, Inc.. The 510(k) number is K893895.

When did HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL receive FDA 510(k) clearance?

HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL received FDA 510(k) clearance on 1989-07-25, under 510(k) number K893895.

Who is the listed applicant for HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL?

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

What is the FDA product code for HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL?

The FDA product code for HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL is JPK.

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Other records listing Intercare Diagnostics, 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.

K941938THE MIRAGE SYSTEM BIOFEEDBACK INTERFACEK920569INDXTM DIP-S-TICKSTMK901597INDX DIP S TICKSK862948CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)

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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