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FDA 510(k)

CORATOMIC MODEL OVALITH-920BP

K-Number: K811768 · 1981-07-20

ApplicantCorptomic
Decision Date1981-07-20
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORATOMIC MODEL OVALITH-920BP is the device name listed in this FDA 510(k) record. The listed applicant is Corptomic. It received FDA 510(k) clearance on 1981-07-20 under 510(k) number K811768. 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 CORATOMIC MODEL OVALITH-920BP?

CORATOMIC MODEL OVALITH-920BP is a medical device that received FDA 510(k) clearance on 1981-07-20. The listed applicant is Corptomic. The 510(k) number is K811768.

When did CORATOMIC MODEL OVALITH-920BP receive FDA 510(k) clearance?

CORATOMIC MODEL OVALITH-920BP received FDA 510(k) clearance on 1981-07-20, under 510(k) number K811768.

Who is the listed applicant for CORATOMIC MODEL OVALITH-920BP?

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

What is the FDA product code for CORATOMIC MODEL OVALITH-920BP?

The FDA product code for CORATOMIC MODEL OVALITH-920BP is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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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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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