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FDA 510(k)

MDI SCL-70 TEST

K-Number: K000934 · 2000-04-07

ApplicantMicro Detect, Inc.
Decision Date2000-04-07
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MDI SCL-70 TEST is the device name listed in this FDA 510(k) record. The listed applicant is Micro Detect, Inc.. It received FDA 510(k) clearance on 2000-04-07 under 510(k) number K000934. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MDI SCL-70 TEST?

MDI SCL-70 TEST is a medical device that received FDA 510(k) clearance on 2000-04-07. The listed applicant is Micro Detect, Inc.. The 510(k) number is K000934.

When did MDI SCL-70 TEST receive FDA 510(k) clearance?

MDI SCL-70 TEST received FDA 510(k) clearance on 2000-04-07, under 510(k) number K000934.

Who is the listed applicant for MDI SCL-70 TEST?

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

What is the FDA product code for MDI SCL-70 TEST?

The FDA product code for MDI SCL-70 TEST is LJM.

Other records listing Micro Detect, 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.

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Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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