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FDA 510(k)

MODEL 4900 OFF-LINE PREPARATION SYSTEM

K-Number: K801271 · 1980-06-09

ApplicantPm America, Inc.
Decision Date1980-06-09
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODEL 4900 OFF-LINE PREPARATION SYSTEM 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 1980-06-09 under 510(k) number K801271. 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 MODEL 4900 OFF-LINE PREPARATION SYSTEM?

MODEL 4900 OFF-LINE PREPARATION SYSTEM is a medical device that received FDA 510(k) clearance on 1980-06-09. The listed applicant is Pm America, Inc.. The 510(k) number is K801271.

When did MODEL 4900 OFF-LINE PREPARATION SYSTEM receive FDA 510(k) clearance?

MODEL 4900 OFF-LINE PREPARATION SYSTEM received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801271.

Who is the listed applicant for MODEL 4900 OFF-LINE PREPARATION SYSTEM?

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 MODEL 4900 OFF-LINE PREPARATION SYSTEM?

The FDA product code for MODEL 4900 OFF-LINE PREPARATION SYSTEM is JQW.

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.

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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.

K830319AUTO PREPK820748POLI-MAK MODEL F-4 (FINALK813102POLI-MAK IIK812983DSD

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

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