FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
K Number: K000462
·
Decision Apr 6, 2000
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
87
Applicant Total
343
Review Days
55
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
- URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
- K Number
- K000462
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- February 11, 2000
- Decision Date
- April 6, 2000
- Product Code
- LCM
- Advisory Committee
- Unknown
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCM), ordered by most recent decision date.
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
FDA 510(k)
FDA Unclassified
·Unknown
SEFRIA PCP Oral Fluid Enzyme Immunoassay
FDA 510(k)
FDA Unclassified
·Unknown
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
FDA 510(k)
FDA Unclassified
·Unknown
Atellica CH Phencyclidine (Pcp)
FDA 510(k)
FDA Unclassified
·Unknown
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
FDA 510(k)
FDA Unclassified
·Unknown
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Dade Behring, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K093848 | PT-MULTI-CALIBRATOR, MODEL OPAT07 | Dec 20, 2010 | Substantially Equivalent |
| K081161 | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST | Jul 28, 2008 | Substantially Equivalent |
| K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | Jul 21, 2008 | Substantially Equivalent |
| K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | Jun 25, 2008 | Substantially Equivalent |
| K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 | Jun 4, 2008 | Substantially Equivalent |
| K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD | Mar 13, 2008 | Substantially Equivalent |
| K073561 | DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR | Feb 26, 2008 | Substantially Equivalent |
| K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | Feb 21, 2008 | Substantially Equivalent |
| K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | Jan 3, 2008 | Substantially Equivalent |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | Dec 21, 2007 | Substantially Equivalent |