Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

QUICK-COUNT HEMATOLOGY REAGENT KIT

K-Number: K833972 · 1984-02-17

ApplicantSeragen Diagnostics, Inc.
Decision Date1984-02-17
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QUICK-COUNT HEMATOLOGY REAGENT KIT 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 1984-02-17 under 510(k) number K833972. The device is classified under product code GIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICK-COUNT HEMATOLOGY REAGENT KIT?

QUICK-COUNT HEMATOLOGY REAGENT KIT is a medical device that received FDA 510(k) clearance on 1984-02-17. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K833972.

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

QUICK-COUNT HEMATOLOGY REAGENT KIT received FDA 510(k) clearance on 1984-02-17, under 510(k) number K833972.

Who is the listed applicant for QUICK-COUNT HEMATOLOGY REAGENT KIT?

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 REAGENT KIT?

The FDA product code for QUICK-COUNT HEMATOLOGY REAGENT KIT is GIF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)K851663QUICK-COUNT HEMATOLOGY CONTROLSK852260QUICK-CHEM CALIBRATION SETK851520CK/LD ISOENZYMES CONTROLS(HUMAN)K851521LD-1(IMMUNO) SEPARATION SETK850209QUICK-LYTE

View all 20 devices →

Related Devices (Code: GIF)

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.

K883989KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.K883990KVM ISOTONIC DILUENTKvm Technologies, Inc.K882490HYCEL QUICK-LYSING HEMOGLOBIN REAGENTR&D Systems, Inc.K882267SYSMEX QUICKLYSER-II (QLS-200A)Toa Medical Electronics USA, Inc.K881130CELL-DYN ISOTONIC DILUENTAbbott DiagnosticsK873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENTAbbott Diagnostics

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.

↑