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)

KALLESTAD SSA/SSB ENA TEST REAGENTS

K-Number: K862710 · 1986-07-29

ApplicantKallestad Laboratories, Inc.
Decision Date1986-07-29
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KALLESTAD SSA/SSB ENA TEST REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1986-07-29 under 510(k) number K862710. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KALLESTAD SSA/SSB ENA TEST REAGENTS?

KALLESTAD SSA/SSB ENA TEST REAGENTS is a medical device that received FDA 510(k) clearance on 1986-07-29. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K862710.

When did KALLESTAD SSA/SSB ENA TEST REAGENTS receive FDA 510(k) clearance?

KALLESTAD SSA/SSB ENA TEST REAGENTS received FDA 510(k) clearance on 1986-07-29, under 510(k) number K862710.

Who is the listed applicant for KALLESTAD SSA/SSB ENA TEST REAGENTS?

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

What is the FDA product code for KALLESTAD SSA/SSB ENA TEST REAGENTS?

The FDA product code for KALLESTAD SSA/SSB ENA TEST REAGENTS is LLL.

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 Kallestad 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.

K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK855014QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A

View all 92 devices →

Related Devices (Code: LLL)

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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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.

↑