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)

PREP I AUTOMATED SAMPLE PROCESSOR

K-Number: K780933 · 1978-07-27

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1978-07-27
Product CodeLDM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREP I AUTOMATED SAMPLE PROCESSOR is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1978-07-27 under 510(k) number K780933. The device is classified under product code LDM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREP I AUTOMATED SAMPLE PROCESSOR?

PREP I AUTOMATED SAMPLE PROCESSOR is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K780933.

When did PREP I AUTOMATED SAMPLE PROCESSOR receive FDA 510(k) clearance?

PREP I AUTOMATED SAMPLE PROCESSOR received FDA 510(k) clearance on 1978-07-27, under 510(k) number K780933.

Who is the listed applicant for PREP I AUTOMATED SAMPLE PROCESSOR?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREP I AUTOMATED SAMPLE PROCESSOR?

The FDA product code for PREP I AUTOMATED SAMPLE PROCESSOR is LDM.

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 E.I. Dupont DE Nemours & Co., 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

View all 253 devices →

Related Devices (Code: LDM)

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.

K960392CDMBio-RadK961557ALLIANCE 2690 SEPARATIONS MODULEWaters CorporationK942451BIO-RAD CLINICAL DATA MANAGEMENT SYSTEMBio-RadK922388WATERS(TM) LC MODULE I FOR CLINICAL USEMillipore Corp.K920136WATERS 717 AUTOSAMPLERMillipore Corp.K903647MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETEMillipore 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.

↑