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FDA 510(k)

RECONDITIONED ASTRA (TM) 8

K-Number: K883298 · 1989-03-16

ApplicantAssociated Electro-Medical Services, Inc.
Decision Date1989-03-16
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RECONDITIONED ASTRA (TM) 8 is the device name listed in this FDA 510(k) record. The listed applicant is Associated Electro-Medical Services, Inc.. It received FDA 510(k) clearance on 1989-03-16 under 510(k) number K883298. 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 RECONDITIONED ASTRA (TM) 8?

RECONDITIONED ASTRA (TM) 8 is a medical device that received FDA 510(k) clearance on 1989-03-16. The listed applicant is Associated Electro-Medical Services, Inc.. The 510(k) number is K883298.

When did RECONDITIONED ASTRA (TM) 8 receive FDA 510(k) clearance?

RECONDITIONED ASTRA (TM) 8 received FDA 510(k) clearance on 1989-03-16, under 510(k) number K883298.

Who is the listed applicant for RECONDITIONED ASTRA (TM) 8?

The FDA 510(k) record lists Associated Electro-Medical Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RECONDITIONED ASTRA (TM) 8?

The FDA product code for RECONDITIONED ASTRA (TM) 8 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 Associated Electro-Medical Services, 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.

K883350RECONDITIONED ASTRA(TM) 4

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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