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)

PLATELET COUNTING KIT

K-Number: K802636 · 1980-12-11

ApplicantStreck Laboratories, Inc.
Decision Date1980-12-11
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET COUNTING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Streck Laboratories, Inc.. It received FDA 510(k) clearance on 1980-12-11 under 510(k) number K802636. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET COUNTING KIT?

PLATELET COUNTING KIT is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K802636.

When did PLATELET COUNTING KIT receive FDA 510(k) clearance?

PLATELET COUNTING KIT received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802636.

Who is the listed applicant for PLATELET COUNTING KIT?

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

What is the FDA product code for PLATELET COUNTING KIT?

The FDA product code for PLATELET COUNTING KIT is GKL.

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 Streck Laboratories, 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.

K042587RETIC-CHEX FOR CELL-DYNK040107CYTO-CHEX BCTK040025A1C-CELLULARK023656SICKLE-CHEX SOLUBILITY KITK021922MODIFICATION TO PARA 5XK020469CAL-CHEX CD PLUS

View all 70 devices →

Related Devices (Code: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex America, 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.

↑