FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COULTER DART AST (GOT) REAGENT
K Number: K905771
·
Decision Feb 26, 1991
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
138
Applicant Total
101
Review Days
61
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
- COULTER DART AST (GOT) REAGENT
- K Number
- K905771
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Coulter Electronics, Inc.
- Date Received
- December 27, 1990
- Decision Date
- February 26, 1991
- Product Code
- CIT
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CIT), ordered by most recent decision date.
AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVATED ASPARTATE AMINOTRANSFERASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COBAS C 111 ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Coulter Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923951 | CD8 CYTOSPHERES KIT | Apr 25, 1994 | Substantially Equivalent |
| K930119 | COULTER RETIC-C CELL CONTROL | Apr 5, 1993 | Substantially Equivalent |
| K921279 | CD4 CYTOSPHERES KIT | Dec 29, 1992 | Substantially Equivalent |
| K923530 | COULTER MULTI-Q-PREP | Oct 14, 1992 | Substantially Equivalent |
| K922181 | COULTER MH009 | Aug 17, 1992 | Substantially Equivalent |
| K922704 | COULTER MAXM W/ AUTOLOADER | Jul 27, 1992 | Substantially Equivalent |
| K921567 | COULTER MH017 | Jul 6, 1992 | Substantially Equivalent |
| K912133 | PX COULTER(R) CELL CONTROL | Jul 17, 1991 | Substantially Equivalent |
| K911385 | COULTER(R) MH010 | Jun 17, 1991 | Substantially Equivalent |
| K905767 | COULTER DART ALT (GPT) REAGENT | Jan 25, 1991 | Substantially Equivalent |