Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1020](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1020) → CJN — Acid Phosphatase, Nitrophenylphosphate

# CJN · Acid Phosphatase, Nitrophenylphosphate

_Clinical Chemistry · 21 CFR 862.1020 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJN

## Overview

- **Product Code:** CJN
- **Device Name:** Acid Phosphatase, Nitrophenylphosphate
- **Regulation:** [21 CFR 862.1020](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1020)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.

## 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 § 862.9.

## 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 § 862.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K781489](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJN/K781489.md) | ACID PHOSPHATASE DIAG. KIT | Sclavo, Inc. | Oct 3, 1978 | SESE |

## Top Applicants

- Sclavo, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJN](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJN)

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