510(k) K041871
- Device
- INTERLAB MICROCAL SERUM CONTROLS
- Applicant
- Trouble Shooter Consuling, Inc.
- 510(k) number
- K041871
- Product code
- JJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-08-16
- Date received
- 2004-07-09
- Regulation
- 862.1660
- Classification name
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Gary Lehnus
- Address
- Via Rina Monti N 26 C.A.P. Rome IT 00155 00155
FDA Registration Numbers#
- 1066444
- 2030538
- 3011420269
- 2030861
- 3007134734
- 3004167884
- 3012422258
- 3006198300
- 3013660430
- 3007349751
- 3002806944
- 3001452053
- 3009491259
- 3007363438
- 1122376
- 3006532271
- 9610240
- 1220649
- 1645225
- 9681576
- 3015347724
- 3009901017
- 1000115322
- 8020888
- 3004176168
- 3003132490
- 1219029
- 3012133212
- 3002807722
- 9610806
- 3042026207
- 9610102
- 3010131137
- 3037000637
- 1318354
- 3017772438
- 3009092698
- 3010713600
- 3004183148
- 3005621222
- 3008606429
- 2434178
- 3005862821
- 3009189893
- 3030186688
- 3033751096
- 1717966
- 3004130086
- 2246703
- 8043909
- 1643621
- 3004145393
- 3003917514
- 3005529799
- 3002694097
- 3007710663
- 2050010
- 3009129531
- 2024674
- 3004434309
- 3005395953
- 2030633
- 3008780388
- 3004152597
- 2032087
- 1218959
- 3014353045
- 3033507883
- 3012113276
- 3007111389
- 9616936
- 3005847079
- 3016438761
- 1000403749
- 1226774
- 3011213605
- 3000308930
- 1649661
- 3016863723
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JJX#
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|---|---|---|---|
| K170678 | Beta-CrossLaps CalCheck 5 | Roche Diagnostics | 2017-04-04 |
| K162173 | Elecsys CYFRA 21-1 CalCheck 5 | Roche Diagnostics | 2017-01-12 |
| K162514 | Multichem A1c | Technopath Manufacturing | 2016-10-26 |
| K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose | Aalto Scientific, Ltd. | 2016-08-10 |
| K161526 | LIAISON CMV IgM Serum Control Set | DiaSorin, Inc. | 2016-06-30 |
| K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin, Inc. | 2016-06-30 |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | Immunodiagnostic Systems , Ltd. | 2016-05-17 |
| K152117 | Dropper hsCRP High Sensitivity CRP Control | Quantimetrix Corporation | 2016-04-21 |
| K151742 | Contour Next Control Solution | Bayer Healthcare | 2015-09-23 |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material | Siemens Healthcare Diagnostics, Inc. | 2015-07-17 |
| K150955 | Elecsys Progesterone III Cal Check 5 | Roche Diagnostics | 2015-05-01 |
| K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | Siemens Healthcare Diagnostics | 2015-04-13 |
| K143324 | IDS-iSYS CTX-I Calibration Verifiers | Immunodiagnostic Systems , Ltd. | 2015-03-30 |
| K143373 | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2015-02-26 |
| K143636 | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2015-02-25 |