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)

RHODAMINE-CONJUGATED ANTISERUM

K-Number: K771144 · 1977-07-14

ApplicantKent Laboratories, Inc.
Decision Date1977-07-14
Product CodeDBY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHODAMINE-CONJUGATED ANTISERUM is the device name listed in this FDA 510(k) record. The listed applicant is Kent Laboratories, Inc.. It received FDA 510(k) clearance on 1977-07-14 under 510(k) number K771144. The device is classified under product code DBY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHODAMINE-CONJUGATED ANTISERUM?

RHODAMINE-CONJUGATED ANTISERUM is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K771144.

When did RHODAMINE-CONJUGATED ANTISERUM receive FDA 510(k) clearance?

RHODAMINE-CONJUGATED ANTISERUM received FDA 510(k) clearance on 1977-07-14, under 510(k) number K771144.

Who is the listed applicant for RHODAMINE-CONJUGATED ANTISERUM?

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

What is the FDA product code for RHODAMINE-CONJUGATED ANTISERUM?

The FDA product code for RHODAMINE-CONJUGATED ANTISERUM is DBY.

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 Kent 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.

K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITK951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITK951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITK950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITK85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

View all 40 devices →

Related Devices (Code: DBY)

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.

K022067CONVOY ADVANCED DELIVERY SHEATHBoston ScientificK013919TORFLEX TRANSSEPTAL GUIDING SHEATHBaylis Medical Co., Inc.K013304BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCERBecton Dickinson Infusion Therapy Systems, Inc.K013282GORE INTRODUCER SHEATHW. L. Gore & Associates, Inc.K013866CONVOY ADVANCED DELIVERY SHEATH KITBoston Scientific

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.

↑