SERUM CHOLINESTERASE REAGENT SET
FDA 510(k) clearance K833062 · decided 1983-11-25
Clearance details
- K-number
- K833062
- Device name
- SERUM CHOLINESTERASE REAGENT SET
- Applicant
- Sterling Biochemical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-08
- Decision date
- 1983-11-25
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- DLI
- Device class
- 1
- Regulation number
- 862.3240
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD (K950180) | E.I. Dupont DE Nemours & Co., Inc. | 1995-03-15 |
| CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO (K930208) | Heraeus Kulzer, Inc. | 1993-04-20 |
| SERUM CHOLINESTERASE REAGENT SET (K860350) | Sterling Diagnostics, Inc. | 1986-04-24 |
| EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 (K860641) | Em Diagnostic Systems, Inc. | 1986-04-03 |
| CHOLINESTERASE REAGENT SYSTEM (K771024) | American Monitor Corp. | 1977-07-15 |
Recalls involving this device
No recalls on record reference this clearance.