510(k) K833062
- Device
- SERUM CHOLINESTERASE REAGENT SET
- Applicant
- STERLING BIOCHEMICAL, INC.
- 510(k) number
- K833062
- Product code
- DLI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-11-25
- Date received
- 1983-09-08
- Regulation
- 862.3240
- Classification name
- Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9681753
- 3042228064
- 3043012240
- 2517506
- 3043011436
- 3043149902
- 3043012074
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DLI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950180 | DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1995-03-15 |
| K930208 | CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO | Heraeus Kulzer, Inc. | 1993-04-20 |
| K860350 | SERUM CHOLINESTERASE REAGENT SET | Sterling Diagnostics, Inc. | 1986-04-24 |
| K860641 | EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 | Em Diagnostic Systems, Inc. | 1986-04-03 |
| K771024 | CHOLINESTERASE REAGENT SYSTEM | American Monitor Corp. | 1977-07-15 |
Legacy Summary#
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FDA Review#
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