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)

AUTO PREP

K-Number: K830319 · 1983-03-29

ApplicantPm America, Inc.
Decision Date1983-03-29
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTO PREP is the device name listed in this FDA 510(k) record. The listed applicant is Pm America, Inc.. It received FDA 510(k) clearance on 1983-03-29 under 510(k) number K830319. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO PREP?

AUTO PREP is a medical device that received FDA 510(k) clearance on 1983-03-29. The listed applicant is Pm America, Inc.. The 510(k) number is K830319.

When did AUTO PREP receive FDA 510(k) clearance?

AUTO PREP received FDA 510(k) clearance on 1983-03-29, under 510(k) number K830319.

Who is the listed applicant for AUTO PREP?

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

What is the FDA product code for AUTO PREP?

The FDA product code for AUTO PREP is JQW.

Other records listing Pm America, 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.

K820748POLI-MAK MODEL F-4 (FINALK813102POLI-MAK IIK812983DSDK801271MODEL 4900 OFF-LINE PREPARATION SYSTEM

Related Devices (Code: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics

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.

↑