FDA 510(k)

MULTILITH 3 MODELS 1350, 3350, 1370, 3370

K-Number: K863898 · 1987-02-10

Decision Date1987-02-10

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MULTILITH 3 MODELS 1350, 3350, 1370, 3370 is the device name listed in this FDA 510(k) record. The listed applicant is Ela Medical, Inc.. It received FDA 510(k) clearance on 1987-02-10 under 510(k) number K863898. 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 MULTILITH 3 MODELS 1350, 3350, 1370, 3370?

MULTILITH 3 MODELS 1350, 3350, 1370, 3370 is a medical device that received FDA 510(k) clearance on 1987-02-10. The listed applicant is Ela Medical, Inc.. The 510(k) number is K863898.

When did MULTILITH 3 MODELS 1350, 3350, 1370, 3370 receive FDA 510(k) clearance?

MULTILITH 3 MODELS 1350, 3350, 1370, 3370 received FDA 510(k) clearance on 1987-02-10, under 510(k) number K863898.

Who is the listed applicant for MULTILITH 3 MODELS 1350, 3350, 1370, 3370?

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

What is the FDA product code for MULTILITH 3 MODELS 1350, 3350, 1370, 3370?

The FDA product code for MULTILITH 3 MODELS 1350, 3350, 1370, 3370 is DXY. This falls under the Clinical Chemistry category.

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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.