Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

N-TACT(R) PTH SP KIT

K-Number: K921629 · 1992-05-14

ApplicantIncstar Corp.
Decision Date1992-05-14
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N-TACT(R) PTH SP KIT is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1992-05-14 under 510(k) number K921629. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N-TACT(R) PTH SP KIT?

N-TACT(R) PTH SP KIT is a medical device that received FDA 510(k) clearance on 1992-05-14. The listed applicant is Incstar Corp.. The 510(k) number is K921629.

When did N-TACT(R) PTH SP KIT receive FDA 510(k) clearance?

N-TACT(R) PTH SP KIT received FDA 510(k) clearance on 1992-05-14, under 510(k) number K921629.

Who is the listed applicant for N-TACT(R) PTH SP KIT?

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

What is the FDA product code for N-TACT(R) PTH SP KIT?

The FDA product code for N-TACT(R) PTH SP KIT is CEW.

Other records listing Incstar Corp. 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.

K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K960367INCSTAR RUBELLA IGG ELISA ASSAYK960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

View all 58 devices →

Related Devices (Code: CEW)

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.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

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.

↑