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FDA 510(k)

PHOSPHORUS TEST ITEM NUMBER 65416

K-Number: K894288 · 1989-08-31

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-08-31
Product CodeCED
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHOSPHORUS TEST ITEM NUMBER 65416 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1989-08-31 under 510(k) number K894288. The device is classified under product code CED. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOSPHORUS TEST ITEM NUMBER 65416?

PHOSPHORUS TEST ITEM NUMBER 65416 is a medical device that received FDA 510(k) clearance on 1989-08-31. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K894288.

When did PHOSPHORUS TEST ITEM NUMBER 65416 receive FDA 510(k) clearance?

PHOSPHORUS TEST ITEM NUMBER 65416 received FDA 510(k) clearance on 1989-08-31, under 510(k) number K894288.

Who is the listed applicant for PHOSPHORUS TEST ITEM NUMBER 65416?

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

What is the FDA product code for PHOSPHORUS TEST ITEM NUMBER 65416?

The FDA product code for PHOSPHORUS TEST ITEM NUMBER 65416 is CED.

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Other records listing Em Diagnostic Systems, 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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Related Devices (Code: CED)

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.

K840151EKTACHEM CLINICAL CHEM. SLIDESEastman Kodak CompanyK833710BTC URINE LH ASSAYBtc Diagnostics, Inc.K820832PHOSPHORUS ILAmerican Monitor Corp.K812670SANDARE FAST 340 PHOSPHORUS PROCEDURESandare Chemical Co., Inc.K811864SIGMA PROCEDURE 265-UVSigma Chemical Co.K811222INORGANIC PHOSPHORUS REAGENTSConnecticut Diagnostics, Ltd.

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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