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FDA 510(k)

MICRO-PLATE READER, MDX-1

K-Number: K894400 · 1989-10-23

ApplicantMedix Biotech, Inc.
Decision Date1989-10-23
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICRO-PLATE READER, MDX-1 is the device name listed in this FDA 510(k) record. The listed applicant is Medix Biotech, Inc.. It received FDA 510(k) clearance on 1989-10-23 under 510(k) number K894400. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-PLATE READER, MDX-1?

MICRO-PLATE READER, MDX-1 is a medical device that received FDA 510(k) clearance on 1989-10-23. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K894400.

When did MICRO-PLATE READER, MDX-1 receive FDA 510(k) clearance?

MICRO-PLATE READER, MDX-1 received FDA 510(k) clearance on 1989-10-23, under 510(k) number K894400.

Who is the listed applicant for MICRO-PLATE READER, MDX-1?

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

What is the FDA product code for MICRO-PLATE READER, MDX-1?

The FDA product code for MICRO-PLATE READER, MDX-1 is JJX.

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Other records listing Medix Biotech, 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.

K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)K952319CONTRAST & RAPID HCG URINE/SERUM TSTK932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KITK925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KITK924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

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Related Devices (Code: JJX)

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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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