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FDA 510(k)

ELS 1000

K-Number: K933548 · 1993-10-29

ApplicantBio-Tek Instruments, Inc.
Decision Date1993-10-29
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELS 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1993-10-29 under 510(k) number K933548. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELS 1000?

ELS 1000 is a medical device that received FDA 510(k) clearance on 1993-10-29. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K933548.

When did ELS 1000 receive FDA 510(k) clearance?

ELS 1000 received FDA 510(k) clearance on 1993-10-29, under 510(k) number K933548.

Who is the listed applicant for ELS 1000?

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

What is the FDA product code for ELS 1000?

The FDA product code for ELS 1000 is JJE.

Other records listing Bio-Tek Instruments, Inc. as applicant

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Related Devices (Code: JJE)

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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