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FDA 510(k)

RIALYZE HPL (RIA)

K-Number: K770659 · 1977-05-20

ApplicantMiles Laboratories, Inc.
Decision Date1977-05-20
Product CodeJMF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIALYZE HPL (RIA) is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1977-05-20 under 510(k) number K770659. The device is classified under product code JMF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIALYZE HPL (RIA)?

RIALYZE HPL (RIA) is a medical device that received FDA 510(k) clearance on 1977-05-20. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K770659.

When did RIALYZE HPL (RIA) receive FDA 510(k) clearance?

RIALYZE HPL (RIA) received FDA 510(k) clearance on 1977-05-20, under 510(k) number K770659.

Who is the listed applicant for RIALYZE HPL (RIA)?

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

What is the FDA product code for RIALYZE HPL (RIA)?

The FDA product code for RIALYZE HPL (RIA) is JMF.

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Other records listing Miles Laboratories, Inc. as applicant

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Related Devices (Code: JMF)

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.

K944933IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)Diagnostic Products Corp.K840588AMERLEX HUMAN PLACENTAL LACTOGENAmersham Corp.K823292IMMOPHASE TM HPL RADIOIMMUNOASSAYCorning Medical & ScientificK823201HUMAN PLACENTAL LACTOGEN KITDiagnostic Products Corp.K811370NATAL-TEC HPLArmkel, LLCK802454GESTE FOLLOW KIT DETERM. OF HPLSyn-Kit, 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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