GP3%SP-2100DOHON100/120 MESH SUPELCOPORT
FDA 510(k) clearance K761226 · decided 1977-01-14
Clearance details
- K-number
- K761226
- Device name
- GP3%SP-2100DOHON100/120 MESH SUPELCOPORT
- Applicant
- Supelco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-12-09
- Decision date
- 1977-01-14
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- JSQ
- Device class
- 1
- Regulation number
- 862.2250
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CYSTINE TRYPTIC MEDIUM (K834007) | Micro Media Laboratories | 1983-12-22 |
| NUTRIENT AGAR (K811138) | Acumedia Manufacturers, Inc. | 1981-05-05 |
Recalls involving this device
No recalls on record reference this clearance.