Company ยท US
Perkinelmer Life Sciences, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2004. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIA | Enzymatic Methods, Galactose | 3 |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| JJN | Apparatus, Electrophoresis, For Clinical Use | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 |
| JLJ | Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate | 1 |
| JNB | Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | 1 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 |
| NQL | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2017 | Perkinelmer Life Sciences, Inc. JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample pr Terminated |
JQW | None listed |
| May 22, 2017 | Perkinelmer Life Sciences, Inc. Multiphor II Electrophoresis System
GE HealthCare Product Number: 18-1018-06
PerkinElmer Part Number: 2117-004
Product Usage:
Multiphor II Electrophoresis System is a versatile modular electr Terminated |
JJN | K050709 |
| Sep 12, 2003 | Perkinelmer Life Sciences, Inc. Angiotensin I [125I] Radioimmunoassay Kit, 500 Tube
Catalog Number: NEA105
For in-vitro diagnostic use Terminated |
CIB | K850054 |
| Sep 12, 2003 | Perkinelmer Life Sciences, Inc. Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube
Catalog Number: NEA104
For in-vitro diagnostic use Terminated |
CIB | K850054 |
| Aug 20, 2003 | Perkinelmer Life Sciences, Inc. Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use
Catalog Number: NEA 103 Terminated |
DHN | K843347 |
| Aug 20, 2003 | PerkinElmer Life Sciences Inc Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100. Terminated |
JLJ | K950803 |
| Jul 2, 2003 | PerkinElmer Life Sciences Inc Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays. Terminated |
JIA | K950481 |
| Jul 2, 2003 | PerkinElmer Life Sciences Inc Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays. Terminated |
JIA | K950481 |
| Jul 2, 2003 | PerkinElmer Life Sciences Inc Neonatal Total Galactose Test Kit, Item #NG-1000, Filter #903, contents for 960 assays. Terminated |
JIA | K950481 |
| Jul 2, 2003 | PerkinElmer LIfe Sciences Inc Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050. Terminated |
K843122 | |
| May 29, 2003 | PerkinElmer LIfe Sciences Inc Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100. Terminated |
JJT | K950803 |