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FDA 510(k)

BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT

K-Number: K983113 · 1998-11-18

ApplicantSyntron Bioresearch, Inc.
Decision Date1998-11-18
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Syntron Bioresearch, Inc.. It received FDA 510(k) clearance on 1998-11-18 under 510(k) number K983113. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT?

BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT is a medical device that received FDA 510(k) clearance on 1998-11-18. The listed applicant is Syntron Bioresearch, Inc.. The 510(k) number is K983113.

When did BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT receive FDA 510(k) clearance?

BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT received FDA 510(k) clearance on 1998-11-18, under 510(k) number K983113.

Who is the listed applicant for BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT?

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

What is the FDA product code for BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT?

The FDA product code for BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT is CEP.

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Related Devices (Code: CEP)

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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