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FDA 510(k)

MODEL 90 BC

K-Number: K821415 · 1982-05-27

ApplicantWestern Laboratories Corp.
Decision Date1982-05-27
Product CodeFLB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL 90 BC is the device name listed in this FDA 510(k) record. The listed applicant is Western Laboratories Corp.. It received FDA 510(k) clearance on 1982-05-27 under 510(k) number K821415. The device is classified under product code FLB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 90 BC?

MODEL 90 BC is a medical device that received FDA 510(k) clearance on 1982-05-27. The listed applicant is Western Laboratories Corp.. The 510(k) number is K821415.

When did MODEL 90 BC receive FDA 510(k) clearance?

MODEL 90 BC received FDA 510(k) clearance on 1982-05-27, under 510(k) number K821415.

Who is the listed applicant for MODEL 90 BC?

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

What is the FDA product code for MODEL 90 BC?

The FDA product code for MODEL 90 BC is FLB.

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Other records listing Western Laboratories Corp. 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.

K834024HEPARINOMETERK830468MODEL 200K821834MODEL 100 BICARBONATE CONDUCTIVITYK821414MODEL 80 BCK801303MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TESTK780932MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT

View all 7 devices →

Related Devices (Code: FLB)

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.

K100237DIALYSATE METER, MODEL D-6Myron L CompanyK92521090DX MULTITEST METER, MODIFICATIONMesa Medical, Inc.K882032MODEL 90DX MULTITEST METERMesa Medical, Inc.K830629COBE RX METERCobe Laboratories, Inc.K770263DIALYSATE METER RS-2100A, CIRCUIT CHANGERenal Systems, 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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