← Product Code [CKB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB) · K875209

# ACID PHOSPHATASE (KINETIC) CAT. # 320-06 (K875209)

_Diagnostic Chemicals, Ltd. (Usa) · CKB · Feb 1, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K875209

## Device Facts

- **Applicant:** Diagnostic Chemicals, Ltd. (Usa)
- **Product Code:** [CKB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB.md)
- **Decision Date:** Feb 1, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1020
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K875209](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K875209)

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