Product Code: JJC
FDA class 1
21 CFR 862.2150
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Clinical Chemistry
This device is a sequential multiple continuous-flow chemistry analyzer used in clinical laboratories to perform automated, high-throughput measurement of multiple chemical analytes in patient specimens simultaneously, supporting diagnosis and monitoring of a wide range of conditions. It is classified as FDA Class 1, subject to general controls only with no premarket notification required. The product code is JJC, regulated under 21 CFR 862.2150, and assigned to the Clinical Chemistry medical specialty.
510(k)s
32
FEI Numbers
16
Registration Numbers
16
Unique Applicants
20
Years Active
19
Basic Information
- Product Code
- JJC
- Device Class
- FDA class 1
- Regulation Number
- 862.2150
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 32 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K945915 | AVL OMNI ANALYZER | Apr 05, 1995 | Substantially Equivalent | AVL SCIENTIFIC CORP. |
| K945584 | NOVA 16 ANALYZER | Feb 08, 1995 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K943376 | OPERA SYSTEM | Sep 14, 1994 | Substantially Equivalent | MILES, INC. |
| K901410 | TECHNICON RA-2000(TM) SYSTEM | Jul 17, 1990 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K901141 | PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX | Apr 09, 1990 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | Feb 17, 1989 | Substantially Equivalent | ALPKEM CORP. |
| K881056 | AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 | Nov 15, 1988 | Substantially Equivalent | AMERICAN RESEARCH PRODUCTS CO. |
| K875105 | TECHNICON SMAC 3 SYSTEM | Feb 16, 1988 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K870998 | TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS | May 26, 1987 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K862561 | TECHNICON RA-XT SYSTEM WITH ANALYTES | Oct 20, 1986 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K854345 | TECHNICON RA-500 SYSTEM | Nov 26, 1985 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K852306 | REPLACEMENT REAGENTS FOR SMAC II SYSTEMS | Aug 02, 1985 | Substantially Equivalent | METHODIST HOSPITAL OF MEMPHIS |
| K833157 | LANCER ANALYZER CUPS | Dec 08, 1983 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K833023 | TECHNICON RA-1000 SYSTEM | Nov 03, 1983 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K823233 | SBA 300 CLINICAL CHEMISTRY ANALYZER | Nov 29, 1982 | Substantially Equivalent | GILFORD INSTRUMENT LABORATORIES, INC. |
| K813077 | TECHNICON RA 1000 SYSTEM | Nov 16, 1981 | Substantially Equivalent | TECHNICON CORP. |
| K811249 | TECHNICON SMAC II SYSTEM & ACCESSORIES | May 21, 1981 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K810394 | PRE-VAP CAPS | Mar 06, 1981 | Substantially Equivalent | SHERMAN BOOSALIS |
| K801481 | BMC RIAFLO SYSTEM | Aug 20, 1980 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K800587 | NSI WASH SOLUTION CONCENTRATE | Aug 08, 1980 | Substantially Equivalent | NOBEL SCIENTIFIC INDUSTRIES, INC. |
| K800453 | PHOTOVOLT PVA 4M+2 ANALYZER | Mar 20, 1980 | Substantially Equivalent | PHOTOVOLT CORP. |
| K792285 | TECHNICON C800 SYSTEM | Dec 06, 1979 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K781503 | TECHNICON STAT/LYTE ISE ELECTROLYTE | Sep 27, 1978 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K771662 | AUTOMATIC ANALYZER | Dec 06, 1977 | Substantially Equivalent | LACHAT CHEMICALS, INC. |
| K771336 | SMA II | Aug 26, 1977 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K770506 | IN VITRO DIAGNOSTIC REAGENTS | May 06, 1977 | Substantially Equivalent | NORWOOD SCIENTIFIC ASSOCIATES, INC. |
| K761342 | SMA MICROLYZER | Feb 01, 1977 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K761086 | REAGENTS | Jan 12, 1977 | Substantially Equivalent | SIMMLER & SON, INC. |
| K760749 | SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY | Dec 29, 1976 | Substantially Equivalent | GILFORD INSTRUMENT LABORATORIES, INC. |
| K761165 | MT II - TEST FOR CONTINUOUS FLOW ANAL | Dec 13, 1976 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K760622 | LANCER AUTOANALYZER MANIFOLD PUMP TUB | Nov 24, 1976 | Substantially Equivalent | SHERWOOD MEDICAL INDUSTRIES |
| K760211 | ANALYZER, GLUCOSE/UREA/CREATININE | Aug 26, 1976 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.