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FDA 510(k)

SPERM CAPACITATION MEDIUM

K-Number: K861188 · 1987-01-06

ApplicantIrvine Scientific
Decision Date1987-01-06
Product CodeHDR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPERM CAPACITATION MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Scientific. It received FDA 510(k) clearance on 1987-01-06 under 510(k) number K861188. The device is classified under product code HDR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPERM CAPACITATION MEDIUM?

SPERM CAPACITATION MEDIUM is a medical device that received FDA 510(k) clearance on 1987-01-06. The listed applicant is Irvine Scientific. The 510(k) number is K861188.

When did SPERM CAPACITATION MEDIUM receive FDA 510(k) clearance?

SPERM CAPACITATION MEDIUM received FDA 510(k) clearance on 1987-01-06, under 510(k) number K861188.

Who is the listed applicant for SPERM CAPACITATION MEDIUM?

The FDA 510(k) record lists Irvine Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPERM CAPACITATION MEDIUM?

The FDA product code for SPERM CAPACITATION MEDIUM is HDR.

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Other records listing Irvine Scientific 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.

K160006Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw KitK914541SPERM MAINTENANCE MEDIUM WITH GLYCEROLK900316MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPESK894405HTF WITH ALBUMIN (CATALOG NO. 9994)K894432MODIFIED HAM'S F-10 W/ALBUMINK874668SPERM WASHING MEDIUM #9983 & MODIFIED #9984

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Related Devices (Code: HDR)

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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