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FDA 510(k)

QUICK-COUNT HEMATOLOGY CONTROLS

K-Number: K851663 · 1985-07-23

ApplicantSeragen Diagnostics, Inc.
Decision Date1985-07-23
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QUICK-COUNT HEMATOLOGY CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Seragen Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-07-23 under 510(k) number K851663. 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 QUICK-COUNT HEMATOLOGY CONTROLS?

QUICK-COUNT HEMATOLOGY CONTROLS is a medical device that received FDA 510(k) clearance on 1985-07-23. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K851663.

When did QUICK-COUNT HEMATOLOGY CONTROLS receive FDA 510(k) clearance?

QUICK-COUNT HEMATOLOGY CONTROLS received FDA 510(k) clearance on 1985-07-23, under 510(k) number K851663.

Who is the listed applicant for QUICK-COUNT HEMATOLOGY CONTROLS?

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

What is the FDA product code for QUICK-COUNT HEMATOLOGY CONTROLS?

The FDA product code for QUICK-COUNT HEMATOLOGY CONTROLS is JPK.

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Other records listing Seragen 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.

K872148VIVID CHLAMYDIA(TM)K852260QUICK-CHEM CALIBRATION SETK851520CK/LD ISOENZYMES CONTROLS(HUMAN)K851521LD-1(IMMUNO) SEPARATION SETK850209QUICK-LYTEK844743SERATEST ENA(RNP/SM) DETERMINATION

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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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