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FDA 510(k)

SERUM LIPASE REAGENT SET (TURBIDIMETRIC)

K-Number: K860554 · 1986-03-14

ApplicantSterling Diagnostics, Inc.
Decision Date1986-03-14
Product CodeCFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM LIPASE REAGENT SET (TURBIDIMETRIC) is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-03-14 under 510(k) number K860554. The device is classified under product code CFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERUM LIPASE REAGENT SET (TURBIDIMETRIC)?

SERUM LIPASE REAGENT SET (TURBIDIMETRIC) is a medical device that received FDA 510(k) clearance on 1986-03-14. The listed applicant is Sterling Diagnostics, Inc.. The 510(k) number is K860554.

When did SERUM LIPASE REAGENT SET (TURBIDIMETRIC) receive FDA 510(k) clearance?

SERUM LIPASE REAGENT SET (TURBIDIMETRIC) received FDA 510(k) clearance on 1986-03-14, under 510(k) number K860554.

Who is the listed applicant for SERUM LIPASE REAGENT SET (TURBIDIMETRIC)?

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

What is the FDA product code for SERUM LIPASE REAGENT SET (TURBIDIMETRIC)?

The FDA product code for SERUM LIPASE REAGENT SET (TURBIDIMETRIC) is CFG.

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Other records listing Sterling Diagnostics, 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.

K921412MICROPROTEIN REAGENT SETK914609TRIGLYCERIDES REAGENT SETK914039SODIUM REAGENT SETK914040PHOSPHOLIPID REAGENT SETK862255LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)K861962VANILMANDELIC ACID (VMA) REAGENT SET

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Related Devices (Code: CFG)

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.

K800550LIPASE DETERMINATIONThe Dow Chemical Co.

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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