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FDA 510(k)

POLI-MAK MODEL F-4 (FINAL

K-Number: K820748 · 1982-04-06

ApplicantPm America, Inc.
Decision Date1982-04-06
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POLI-MAK MODEL F-4 (FINAL 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 1982-04-06 under 510(k) number K820748. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLI-MAK MODEL F-4 (FINAL?

POLI-MAK MODEL F-4 (FINAL is a medical device that received FDA 510(k) clearance on 1982-04-06. The listed applicant is Pm America, Inc.. The 510(k) number is K820748.

When did POLI-MAK MODEL F-4 (FINAL receive FDA 510(k) clearance?

POLI-MAK MODEL F-4 (FINAL received FDA 510(k) clearance on 1982-04-06, under 510(k) number K820748.

Who is the listed applicant for POLI-MAK MODEL F-4 (FINAL?

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 POLI-MAK MODEL F-4 (FINAL?

The FDA product code for POLI-MAK MODEL F-4 (FINAL is JJF.

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 PREPK813102POLI-MAK IIK812983DSDK801271MODEL 4900 OFF-LINE PREPARATION SYSTEM

Related Devices (Code: JJF)

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.

K052794ETI-MAX 3000DiaSorin, Inc.K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERPrecision Systems, Inc.K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.K993634CARESIDE ANALYZERCareside, Inc.

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.

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