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FDA 510(k)

ANTI-SCI-70 ANTIBODY TEST

K-Number: K903314 · 1990-08-14

ApplicantImmco Diagnostics, Inc.
Decision Date1990-08-14
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-SCI-70 ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-08-14 under 510(k) number K903314. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-SCI-70 ANTIBODY TEST?

ANTI-SCI-70 ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1990-08-14. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K903314.

When did ANTI-SCI-70 ANTIBODY TEST receive FDA 510(k) clearance?

ANTI-SCI-70 ANTIBODY TEST received FDA 510(k) clearance on 1990-08-14, under 510(k) number K903314.

Who is the listed applicant for ANTI-SCI-70 ANTIBODY TEST?

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

What is the FDA product code for ANTI-SCI-70 ANTIBODY TEST?

The FDA product code for ANTI-SCI-70 ANTIBODY TEST is LLL.

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Related Devices (Code: LLL)

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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.

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