Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart I — Hematology Reagents](/submissions/HE/subpart-i%E2%80%94hematology-reagents) → [21 CFR 864.8175](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8175) → KRY — Calibrator For Platelet Counting

# KRY · Calibrator For Platelet Counting

_Hematology · 21 CFR 864.8175 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY

## Overview

- **Product Code:** KRY
- **Device Name:** Calibrator For Platelet Counting
- **Regulation:** [21 CFR 864.8175](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8175)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A calibrator for platelet counting is a device that resembles platelets in plasma or whole blood and that is used to set a platelet counting instrument. It is a suspension of particles or cells whose size, shape concentration, and other characteristics have been precisely and accurately determined.

## Classification Rationale

Class II (special controls). The device 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). The device 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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K862122](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY/K862122.md) | S-CAL HEMATOLOGY CALIBRATOR | Coulter Electronics, Inc. | May 20, 1987 | SESE |
| [K852016](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY/K852016.md) | LASER PLATELETCAL/MULTIPLE | R&D Systems, Inc. | Jul 9, 1985 | SESE |
| [K843910](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY/K843910.md) | COULTER MEAN PLATELET VOLUME CALIBRATOR | Coulter Electronics, Inc. | Jan 7, 1985 | SESE |
| [K840794](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY/K840794.md) | S-CAL HEMATOLOGY CALIBRATOR | Coulter Electronics, Inc. | Apr 4, 1984 | SESE |
| [K821851](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY/K821851.md) | CONTROL DIAGNOSTICS PLATELET CONTROL | Immunogenetics | Sep 2, 1982 | SESE |
| [K781601](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY/K781601.md) | TEKNI-CAL | Streck Laboratories, Inc. | Oct 10, 1978 | SESE |
| [K781133](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY/K781133.md) | PC-CALIBRATOR | Streck Laboratories, Inc. | Aug 14, 1978 | SESE |
| [K770143](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY/K770143.md) | TQC CALIBRATION REFERENCE FOR PLATELETS | Technicon Instruments Corp. | Jan 30, 1978 | SESE |

## Top Applicants

- Coulter Electronics, Inc. — 3 clearances
- Streck Laboratories, Inc. — 2 clearances
- Immunogenetics — 1 clearance
- R&D Systems, Inc. — 1 clearance
- Technicon Instruments Corp. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com