← Product Code [CKB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB) · K850902

# DATA ZYME ACID PHOSPHATASE PROCEDURE (K850902)

_Data Medical Associates, Inc. · CKB · Mar 20, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K850902

## Device Facts

- **Applicant:** Data Medical Associates, Inc.
- **Product Code:** [CKB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB.md)
- **Decision Date:** Mar 20, 1985
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K850902](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K850902)

**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