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FDA 510(k)

MILES LIPASE SERA-PAK METHOD

K-Number: K920337 · 1992-03-11

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-03-11
Product CodeCHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MILES LIPASE SERA-PAK METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1992-03-11 under 510(k) number K920337. The device is classified under product code CHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILES LIPASE SERA-PAK METHOD?

MILES LIPASE SERA-PAK METHOD is a medical device that received FDA 510(k) clearance on 1992-03-11. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K920337.

When did MILES LIPASE SERA-PAK METHOD receive FDA 510(k) clearance?

MILES LIPASE SERA-PAK METHOD received FDA 510(k) clearance on 1992-03-11, under 510(k) number K920337.

Who is the listed applicant for MILES LIPASE SERA-PAK METHOD?

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

What is the FDA product code for MILES LIPASE SERA-PAK METHOD?

The FDA product code for MILES LIPASE SERA-PAK METHOD is CHI.

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Other records listing Heraeus Kulzer, Inc. as applicant

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K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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Related Devices (Code: CHI)

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.

K970905SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENTBeckman Instruments, Inc.K961179SENTINEL LIPASE LIQUID MODEL 17.401BEqual Diagnostics, Inc.K952180CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMSBeckman Instruments, Inc.K952647IL TEST LIPASEInstrumentation Laboratory COK952816LIPASE FLEX REAGENT CARTRIDGEDupont Medical ProductsK941085LIPASE-PS ASSAY PROCEDURE NO. 805Sigma Diagnostics, 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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