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FDA 510(k)

BIO-2000

K-Number: K973765 · 1998-11-04

ApplicantMicrylium Laboratories
Decision Date1998-11-04
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Micrylium Laboratories. It received FDA 510(k) clearance on 1998-11-04 under 510(k) number K973765. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-2000?

BIO-2000 is a medical device that received FDA 510(k) clearance on 1998-11-04. The listed applicant is Micrylium Laboratories. The 510(k) number is K973765.

When did BIO-2000 receive FDA 510(k) clearance?

BIO-2000 received FDA 510(k) clearance on 1998-11-04, under 510(k) number K973765.

Who is the listed applicant for BIO-2000?

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

What is the FDA product code for BIO-2000?

The FDA product code for BIO-2000 is EIA.

Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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