← Product Code [GGW](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGW) · K902236

# READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT (K902236)

_Biosearch Medical Products, Inc. · GGW · Aug 14, 1990 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-h%E2%80%94hematology-kits-and-packages/GGW/K902236

## Device Facts

- **Applicant:** Biosearch Medical Products, Inc.
- **Product Code:** [GGW](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGW.md)
- **Decision Date:** Aug 14, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7925
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-h%E2%80%94hematology-kits-and-packages/GGW/K902236](https://fda.innolitics.com/submissions/IM/subpart-h%E2%80%94hematology-kits-and-packages/GGW/K902236)

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