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FDA 510(k)

HEMOPLUS

K-Number: K913622 · 1992-01-31

ApplicantSarstedt, Inc.
Decision Date1992-01-31
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOPLUS is the device name listed in this FDA 510(k) record. The listed applicant is Sarstedt, Inc.. It received FDA 510(k) clearance on 1992-01-31 under 510(k) number K913622. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOPLUS?

HEMOPLUS is a medical device that received FDA 510(k) clearance on 1992-01-31. The listed applicant is Sarstedt, Inc.. The 510(k) number is K913622.

When did HEMOPLUS receive FDA 510(k) clearance?

HEMOPLUS received FDA 510(k) clearance on 1992-01-31, under 510(k) number K913622.

Who is the listed applicant for HEMOPLUS?

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

What is the FDA product code for HEMOPLUS?

The FDA product code for HEMOPLUS is KHE.

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Other records listing Sarstedt, Inc. 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.

K051019SAFETY NEEDLEK032150SAFETY-MULTIFLYK031359S-MONOVETTE EDTA K2-GELK024237URINE MONOVETTE BORIC ACIDK003382SARSTEDT NEEDLE PROTECTOR

Related Devices (Code: KHE)

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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