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FDA 510(k)

SEMINAL FLUID COLLECTION KIT(TM)

K-Number: K864473 · 1986-12-03

ApplicantApex Technologies, Inc.
Decision Date1986-12-03
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SEMINAL FLUID COLLECTION KIT(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Apex Technologies, Inc.. It received FDA 510(k) clearance on 1986-12-03 under 510(k) number K864473. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEMINAL FLUID COLLECTION KIT(TM)?

SEMINAL FLUID COLLECTION KIT(TM) is a medical device that received FDA 510(k) clearance on 1986-12-03. The listed applicant is Apex Technologies, Inc.. The 510(k) number is K864473.

When did SEMINAL FLUID COLLECTION KIT(TM) receive FDA 510(k) clearance?

SEMINAL FLUID COLLECTION KIT(TM) received FDA 510(k) clearance on 1986-12-03, under 510(k) number K864473.

Who is the listed applicant for SEMINAL FLUID COLLECTION KIT(TM)?

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

What is the FDA product code for SEMINAL FLUID COLLECTION KIT(TM)?

The FDA product code for SEMINAL FLUID COLLECTION KIT(TM) is HIS.

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Related Devices (Code: HIS)

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.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.

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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