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FDA 510(k)

MRI HCG-BETA RIA KIT CAT. #MR-10100

K-Number: K801491 · 1980-08-13

ApplicantMicroanalytic Research, Inc.
Decision Date1980-08-13
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MRI HCG-BETA RIA KIT CAT. #MR-10100 is the device name listed in this FDA 510(k) record. The listed applicant is Microanalytic Research, Inc.. It received FDA 510(k) clearance on 1980-08-13 under 510(k) number K801491. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRI HCG-BETA RIA KIT CAT. #MR-10100?

MRI HCG-BETA RIA KIT CAT. #MR-10100 is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is Microanalytic Research, Inc.. The 510(k) number is K801491.

When did MRI HCG-BETA RIA KIT CAT. #MR-10100 receive FDA 510(k) clearance?

MRI HCG-BETA RIA KIT CAT. #MR-10100 received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801491.

Who is the listed applicant for MRI HCG-BETA RIA KIT CAT. #MR-10100?

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

What is the FDA product code for MRI HCG-BETA RIA KIT CAT. #MR-10100?

The FDA product code for MRI HCG-BETA RIA KIT CAT. #MR-10100 is JHI.

Other records listing Microanalytic Research, Inc. as applicant

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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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