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FDA 510(k)

APO-TEK LP(A)

K-Number: K970302 · 1997-11-10

ApplicantPerimmune, Inc.
Decision Date1997-11-10
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

APO-TEK LP(A) is the device name listed in this FDA 510(k) record. The listed applicant is Perimmune, Inc.. It received FDA 510(k) clearance on 1997-11-10 under 510(k) number K970302. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APO-TEK LP(A)?

APO-TEK LP(A) is a medical device that received FDA 510(k) clearance on 1997-11-10. The listed applicant is Perimmune, Inc.. The 510(k) number is K970302.

When did APO-TEK LP(A) receive FDA 510(k) clearance?

APO-TEK LP(A) received FDA 510(k) clearance on 1997-11-10, under 510(k) number K970302.

Who is the listed applicant for APO-TEK LP(A)?

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

What is the FDA product code for APO-TEK LP(A)?

The FDA product code for APO-TEK LP(A) is DFC.

Other records listing Perimmune, 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.

K970353AURA TEK FDP

Related Devices (Code: DFC)

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.

K253069Lipoprotein (a) Molarity AssayDiazyme Laboratories, Inc.K241220Tina-quant Lipoprotein(a) Gen.2 MolarityRoche Diagnostics OperationsK211058Lp(a) UltraSENTINEL CH. SpAK180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc.K123046ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORSiemens Healthcare Diagnostics, Inc.K122722COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160Roche Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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