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-CHEX-HUMAN

K-Number: K770020 · 1977-02-16

ApplicantStreck Laboratories, Inc.
Decision Date1977-02-16
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET-CHEX-HUMAN 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 1977-02-16 under 510(k) number K770020. 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 PLATELET-CHEX-HUMAN?

PLATELET-CHEX-HUMAN is a medical device that received FDA 510(k) clearance on 1977-02-16. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K770020.

When did PLATELET-CHEX-HUMAN receive FDA 510(k) clearance?

PLATELET-CHEX-HUMAN received FDA 510(k) clearance on 1977-02-16, under 510(k) number K770020.

Who is the listed applicant for PLATELET-CHEX-HUMAN?

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-CHEX-HUMAN?

The FDA product code for PLATELET-CHEX-HUMAN is JPK.

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: 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.

K160590XN CHECKStreckK160588XN CHECK BFStreckK160586XN-L CHECKStreckK160606BC-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.

↑