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)

STAK-CHEX PLUS RETICS

K-Number: K090137 · 2009-03-18

ApplicantStreck
Decision Date2009-03-18
Product CodeGLQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STAK-CHEX PLUS RETICS is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2009-03-18 under 510(k) number K090137. The device is classified under product code GLQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAK-CHEX PLUS RETICS?

STAK-CHEX PLUS RETICS is a medical device that received FDA 510(k) clearance on 2009-03-18. The listed applicant is Streck. The 510(k) number is K090137.

When did STAK-CHEX PLUS RETICS receive FDA 510(k) clearance?

STAK-CHEX PLUS RETICS received FDA 510(k) clearance on 2009-03-18, under 510(k) number K090137.

Who is the listed applicant for STAK-CHEX PLUS RETICS?

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

What is the FDA product code for STAK-CHEX PLUS RETICS?

The FDA product code for STAK-CHEX PLUS RETICS is GLQ.

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 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.

K254166MDx-Chex for BCNK231223MDx-Chex for BC-GNK231221MDx-Chex for BC-GPK170091UA-Cellular CompleteK160585XN CALK160586XN-L CHECK

View all 28 devices →

Related Devices (Code: GLQ)

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.

K111211CELL-DYN 22 PLUS CONTROLStreckK110718CELL-CHEX WITH CPPD CRYSTALSStreckK101335CELL-CHEXStreckK000945PARA 12 PLUS RETICSStreck Laboratories, Inc.K994388XE CHECKStreck Laboratories, Inc.K992887STAK-CHEX PLUS RETICSStreck Laboratories, 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.

↑