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FDA 510(k)

MIT ONE STEP PREGNANCY TEST

K-Number: K953486 · 1995-12-21

Applicant3c Diagnostics, Inc.
Decision Date1995-12-21
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MIT ONE STEP PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is 3c Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-12-21 under 510(k) number K953486. 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 MIT ONE STEP PREGNANCY TEST?

MIT ONE STEP PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1995-12-21. The listed applicant is 3c Diagnostics, Inc.. The 510(k) number is K953486.

When did MIT ONE STEP PREGNANCY TEST receive FDA 510(k) clearance?

MIT ONE STEP PREGNANCY TEST received FDA 510(k) clearance on 1995-12-21, under 510(k) number K953486.

Who is the listed applicant for MIT ONE STEP PREGNANCY TEST?

The FDA 510(k) record lists 3c Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIT ONE STEP PREGNANCY TEST?

The FDA product code for MIT ONE STEP PREGNANCY TEST is JHI.

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Related Devices (Code: JHI)

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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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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