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)

TITAN GEL HIGH RESOLUTION SERUM PROTEIN

K-Number: K821688 · 1982-06-22

ApplicantHelena Laboratories
Decision Date1982-06-22
Product CodeJJN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TITAN GEL HIGH RESOLUTION SERUM PROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1982-06-22 under 510(k) number K821688. The device is classified under product code JJN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITAN GEL HIGH RESOLUTION SERUM PROTEIN?

TITAN GEL HIGH RESOLUTION SERUM PROTEIN is a medical device that received FDA 510(k) clearance on 1982-06-22. The listed applicant is Helena Laboratories. The 510(k) number is K821688.

When did TITAN GEL HIGH RESOLUTION SERUM PROTEIN receive FDA 510(k) clearance?

TITAN GEL HIGH RESOLUTION SERUM PROTEIN received FDA 510(k) clearance on 1982-06-22, under 510(k) number K821688.

Who is the listed applicant for TITAN GEL HIGH RESOLUTION SERUM PROTEIN?

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

What is the FDA product code for TITAN GEL HIGH RESOLUTION SERUM PROTEIN?

The FDA product code for TITAN GEL HIGH RESOLUTION SERUM PROTEIN is JJN.

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 Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

View all 280 devices →

Related Devices (Code: JJN)

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.

K924021POWER SUPPLYThe Binding Site, Ltd.K924020ELECTROPHORESIS TANKThe Binding Site, Ltd.K882344ELECTR-TRANSBLOTTERThe W.E.P. Co.K881852REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170Helena LaboratoriesK882163HELENA REP GEL PROCESSORHelena LaboratoriesK873352RAPID ELECTROPHORESIS SYSTEM (REP)Helena Laboratories

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.

↑