Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test
FDA 510(k) clearance K252523 · decided 2026-02-12
Clearance details
- K-number
- K252523
- Device name
- Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test
- Applicant
- Healgen Scientific,, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-08-11
- Decision date
- 2026-02-12
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- NFW
- Device class
- 2
- Regulation number
- 862.3870
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Healgen Scientific
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50 (K231978) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-08-31 |
| BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip (K192301) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019-09-20 |
| SAFECARE® THC Urine Strip Test (K191924) | Safecare Biotech (Hangzhou) Co., Ltd. | 2019-08-16 |
Recalls involving this device
No recalls on record reference this clearance.