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FDA 510(k)

RSL INSULIN KIT

K-Number: K772281 · 1978-01-06

ApplicantRadioassay Systems Laboratories, Inc.
Decision Date1978-01-06
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RSL INSULIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Radioassay Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1978-01-06 under 510(k) number K772281. The device is classified under product code CFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RSL INSULIN KIT?

RSL INSULIN KIT is a medical device that received FDA 510(k) clearance on 1978-01-06. The listed applicant is Radioassay Systems Laboratories, Inc.. The 510(k) number is K772281.

When did RSL INSULIN KIT receive FDA 510(k) clearance?

RSL INSULIN KIT received FDA 510(k) clearance on 1978-01-06, under 510(k) number K772281.

Who is the listed applicant for RSL INSULIN KIT?

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

What is the FDA product code for RSL INSULIN KIT?

The FDA product code for RSL INSULIN KIT is CFP.

Related Clinical Trials

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.

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Other records listing Radioassay Systems Laboratories, 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.

K862204RSL (125I) ALDOSTERONE KITK842960ANDROSTENEDIONE BY RIAK840886HYDROXYPROGESTERONE BY RIA 17AK831855HATCH KITK802195DEHYDROEPIANDROSTERONE SULFATE KIT RIAK800126RSL (125 L) PROGESTERONE KIT

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Related Devices (Code: CFP)

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.

K963911ALPCO/MERCODIA INSULIN ELISAAmerican Laboratory Products Co., Ltd.K953084ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.K920109IMX INSULINAbbott LaboratoriesK914820DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.K903628AIA-PACK IRITosoh Corp.K901135ENZYMUN TEST(R) INSULINBoehringer Mannheim Corp.

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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