510(k) K760749
- Device
- SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY
- Applicant
- Gilford Instrument Laboratories, Inc.
- 510(k) number
- K760749
- Product code
- JJC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-29
- Date received
- 1976-09-30
- Regulation
- 862.2150
- Classification name
- Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3012275122
- 3043088937
- 1219913
- 2432235
- 3050015
- 3018771894
- 3016763307
- 3010402964
- 3016837106
- 1219029
- 3027645317
- 8030996
- 3043138885
- 2016673
- 3010031137
- 3003741796
- 3010160538
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JJC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K945915 | AVL OMNI ANALYZER | Avl Scientific Corp. | 1995-04-05 |
| K945584 | NOVA 16 ANALYZER | Nova Biomedical Corp. | 1995-02-08 |
| K943376 | OPERA SYSTEM | Miles, Inc. | 1994-09-14 |
| K901410 | TECHNICON RA-2000(TM) SYSTEM | Technicon Instruments Corp. | 1990-07-17 |
| K901141 | PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX | Baxter Healthcare Corp | 1990-04-09 |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | Alpkem Corp. | 1989-02-17 |
| K881056 | AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 | American Research Products Co. | 1988-11-15 |
| K875105 | TECHNICON SMAC 3 SYSTEM | Technicon Instruments Corp. | 1988-02-16 |
| K870998 | TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS | Technicon Instruments Corp. | 1987-05-26 |
| K862561 | TECHNICON RA-XT SYSTEM WITH ANALYTES | Technicon Instruments Corp. | 1986-10-20 |
| K854345 | TECHNICON RA-500 SYSTEM | Technicon Instruments Corp. | 1985-11-26 |
| K852306 | REPLACEMENT REAGENTS FOR SMAC II SYSTEMS | Methodist Hospital of Memphis | 1985-08-02 |
| K833157 | LANCER ANALYZER CUPS | Sherwood Medical Co. | 1983-12-08 |
| K833023 | TECHNICON RA-1000 SYSTEM | Technicon Instruments Corp. | 1983-11-03 |
| K823233 | SBA 300 CLINICAL CHEMISTRY ANALYZER | Gilford Instrument Laboratories, Inc. | 1982-11-29 |