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)

SCEPTOR SYSTEM AUTOMATED MODEL 216

K-Number: K810229 · 1981-02-09

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1981-02-09
Product CodeJTC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SCEPTOR SYSTEM AUTOMATED MODEL 216 is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1981-02-09 under 510(k) number K810229. The device is classified under product code JTC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCEPTOR SYSTEM AUTOMATED MODEL 216?

SCEPTOR SYSTEM AUTOMATED MODEL 216 is a medical device that received FDA 510(k) clearance on 1981-02-09. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K810229.

When did SCEPTOR SYSTEM AUTOMATED MODEL 216 receive FDA 510(k) clearance?

SCEPTOR SYSTEM AUTOMATED MODEL 216 received FDA 510(k) clearance on 1981-02-09, under 510(k) number K810229.

Who is the listed applicant for SCEPTOR SYSTEM AUTOMATED MODEL 216?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCEPTOR SYSTEM AUTOMATED MODEL 216?

The FDA product code for SCEPTOR SYSTEM AUTOMATED MODEL 216 is JTC.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic 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.

K003062BACTEC MGIT 960 SIR KITSK0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGEK003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLEK002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16K001364BD DIRECTIGEN FLU A+BK000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

View all 632 devices →

Related Devices (Code: JTC)

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.

K924907FILTERMATE UNIVERSAL HARVESTERPackard Instrument Co., Inc.K901808MICROMATE 196 MODEL A961960Packard Instrument Co., Inc.K894645IMMULON 1,2,3,AND 4 DIVIDASTRIPS TMDynatech Laboratories, Inc.K892369MULTI-PROBE HEAD PLUSHamilton Co.K891766GENETIC SYSTEMS MICROPLATE STRIP WASHERGenetic Systems Corp.K891765GENETIC SYSTEMS PIPETTOR/DILUTORGenetic Systems Corp.

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.

↑