FDA 510(k)

TFR

K-Number: K981208 · 1998-10-21

Decision Date1998-10-21

Product CodeJNM

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

TFR is the device name listed in this FDA 510(k) record. The listed applicant is Ramco Laboratories, Inc.. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K981208. The device is classified under product code JNM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TFR?

TFR is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Ramco Laboratories, Inc.. The 510(k) number is K981208.

When did TFR receive FDA 510(k) clearance?

TFR received FDA 510(k) clearance on 1998-10-21, under 510(k) number K981208.

Who is the listed applicant for TFR?

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

What is the FDA product code for TFR?

The FDA product code for TFR is JNM.

Other records listing Ramco 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.

K983107VFE K910481EPO-RIA K872941SPECTRO C K864701VWF IMMUNOBLOT K861159SPECTRO VWF K831470PTH MR

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Related Devices (Code: JNM)

K992188NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028Nichols Institute Diagnostics K970718QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)R&D Systems, 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.