Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7340](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7340) → DAT — Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

# DAT · Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

_Hematology · 21 CFR 864.7340 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAT

## Overview

- **Product Code:** DAT
- **Device Name:** Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 864.7340](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7340)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Identification

A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

## Classification Rationale

Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Special Controls

*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K924892](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAT/K924892.md) | FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM | Organon Teknika Corp. | Apr 21, 1994 | SESE |
| [K781103](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAT/K781103.md) | SPECTRASCAN | Medishield, Inc. | Sep 27, 1978 | SESE |

## Top Applicants

- Medishield, Inc. — 1 clearance
- Organon Teknika Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAT](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAT)

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