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)

JMS NEEDLE & MAC JECT

K-Number: K813648 · 1982-01-28

ApplicantPhiladelphia Biologics Center
Decision Date1982-01-28
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

JMS NEEDLE & MAC JECT is the device name listed in this FDA 510(k) record. The listed applicant is Philadelphia Biologics Center. It received FDA 510(k) clearance on 1982-01-28 under 510(k) number K813648. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JMS NEEDLE & MAC JECT?

JMS NEEDLE & MAC JECT is a medical device that received FDA 510(k) clearance on 1982-01-28. The listed applicant is Philadelphia Biologics Center. The 510(k) number is K813648.

When did JMS NEEDLE & MAC JECT receive FDA 510(k) clearance?

JMS NEEDLE & MAC JECT received FDA 510(k) clearance on 1982-01-28, under 510(k) number K813648.

Who is the listed applicant for JMS NEEDLE & MAC JECT?

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

What is the FDA product code for JMS NEEDLE & MAC JECT?

The FDA product code for JMS NEEDLE & MAC JECT is FMI.

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 Philadelphia Biologics Center 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.

K841717INTRAVENOUS INJECTION SETK834256PBC SYRINGE IRRIGATINGK834255PBC SCALP VEIN SETK834253PBC IV SET NON-VENTEDK834254PBC IV SET VENTEDK834252PBC EXTENSION SET

View all 11 devices →

Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

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.

↑