FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLINESTERASE REAGENT SYSTEM
K Number: K771024
·
Decision Jul 15, 1977
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
5
Applicant Total
73
Review Days
37
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CHOLINESTERASE REAGENT SYSTEM
- K Number
- K771024
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3240
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- American Monitor Corp.
- Date Received
- June 8, 1977
- Decision Date
- July 15, 1977
- Product Code
- DLI
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DLI | Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase | FDA class 1 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DLI), ordered by most recent decision date.
DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD
FDA 510(k)
FDA Class 1
·Clinical Toxicology
CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO
FDA 510(k)
FDA Class 1
·Clinical Toxicology
SERUM CHOLINESTERASE REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Toxicology
EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93
FDA 510(k)
FDA Class 1
·Clinical Toxicology
SERUM CHOLINESTERASE REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Other Clearances by American Monitor Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K895999 | PHOSPHORUS | Jan 11, 1990 | Substantially Equivalent |
| K896000 | ASPARTATE AMINOTRANFERASE (AST) | Jan 11, 1990 | Substantially Equivalent |
| K896001 | ALANINE AMINOTRANSFERASE (ALT) | Nov 13, 1989 | Substantially Equivalent |
| K895423 | ACCESS CHEMISTRY ANALYZER | Oct 4, 1989 | Substantially Equivalent |
| K893137 | EXCEL (TM) CHEMISTRY ANALYZER | Aug 10, 1989 | Substantially Equivalent |
| K892331 | ENZYMATIC UREA NITROGEN REAGENT SET | Jun 20, 1989 | Substantially Equivalent |
| K893479 | CHOLESTEROL REAGENT SET | Jun 19, 1989 | Substantially Equivalent |
| K892002 | NEOCHROME(R) III GLUCOSE | Jun 12, 1989 | Substantially Equivalent |
| K890312 | GAMMA-GLUTAMYLTRANSFERASE | Mar 24, 1989 | Substantially Equivalent |
| K890034 | PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) | Feb 3, 1989 | Substantially Equivalent |