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FDA 510(k)

SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL

K-Number: K881655 · 1988-05-27

ApplicantBiomedical Research & Development Laboratories, Inc.
Decision Date1988-05-27
Product CodeJJR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Research & Development Laboratories, Inc.. It received FDA 510(k) clearance on 1988-05-27 under 510(k) number K881655. The device is classified under product code JJR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL?

SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL is a medical device that received FDA 510(k) clearance on 1988-05-27. The listed applicant is Biomedical Research & Development Laboratories, Inc.. The 510(k) number is K881655.

When did SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL receive FDA 510(k) clearance?

SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL received FDA 510(k) clearance on 1988-05-27, under 510(k) number K881655.

Who is the listed applicant for SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL?

The FDA 510(k) record lists Biomedical Research & Development Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL?

The FDA product code for SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL is JJR.

Related Clinical Trials

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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Other records listing Biomedical Research & Development Laboratories, 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.

K884693UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDSK834474H.P.T. HOME PREG. TEST KIT & A.P.T.

Related Devices (Code: JJR)

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.

K990971EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816Medica Corp.K960592ELECTROLYTE STANDARDSPhoenix Diagnostics, Inc.K955630RNA MEDICAL HEMAT CONTROLBionostics, Inc.K951435AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIALAalto Scientific, Ltd.K943925SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTINGQuantimetrix Corp.K934641I-STAT CONTROL LEVELS 1,2,3I-Stat Corp.

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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