510(k) K943780 ยท JJW Urinalysis Controls (Assayed And Unassayed)
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
| Applicant | Heraeus Kulzer, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Oct 31, 1994 |
| Received | Aug 3, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943780
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry
Catalog Number:1360
Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strip Terminated |
JJW | None listed |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine
Chemistry
Catalog Number: 5019
When used with the CLINITEK ATLAS Automated urine Chemistry Analyzer and CLINITEK ATLAS 10 reagent Terminated |
JJW | None listed |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens Chek-Stix Combo Pak
Catalog Number: 1364
Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX posit Terminated |
JJW | None listed |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry
(Distributed OUS Only)
Catalog Number: 1360L
Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used w Terminated |
JJW | None listed |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens Chek-Stix Combo Pak (Distributed OUS only)
Catalog Number: 1364M
Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urin Terminated |
JJW | None listed |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens Chek-Stix Combo Pak
(Distributed OUS only)
Catalog Number: 1364N
Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for uri Terminated |
JJW | None listed |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens Chek-Stix Combo Pak
(Distributed OUS)
Catalog Number: 1364E
Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysi Terminated |
JJW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.