FDA 510(k)

QUANTUM MODELS 253-09, 254-09 254-10

K-Number: K820853 · 1982-04-09

Decision Date1982-04-09

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

QUANTUM MODELS 253-09, 254-09 254-10 is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1982-04-09 under 510(k) number K820853. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTUM MODELS 253-09, 254-09 254-10?

QUANTUM MODELS 253-09, 254-09 254-10 is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is Intermedics, Inc.. The 510(k) number is K820853.

When did QUANTUM MODELS 253-09, 254-09 254-10 receive FDA 510(k) clearance?

QUANTUM MODELS 253-09, 254-09 254-10 received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820853.

Who is the listed applicant for QUANTUM MODELS 253-09, 254-09 254-10?

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

What is the FDA product code for QUANTUM MODELS 253-09, 254-09 254-10?

The FDA product code for QUANTUM MODELS 253-09, 254-09 254-10 is DXY. This falls under the Clinical Chemistry category.

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Other records listing Intermedics, Inc. as applicant

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Related Devices (Code: DXY)

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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.