510(k) K843839
- Device
- STAT/PB REAGENT
- Applicant
- TRI-TECH, INC.
- 510(k) number
- K843839
- Product code
- DOF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-01-03
- Date received
- 1984-10-01
- Regulation
- 862.3550
- Classification name
- Lead, Atomic Absorption
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAY W WALKER
- Address
- 5120 Revere Rd. Durham NC US 27713 27713
FDA Registration Numbers#
- 3043226252
- 3012494290
- 1218996
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DOF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142705 | LeadCare Plus Blood Lead Testing System | Magellan Diagnostics | 2015-07-07 |
| K123563 | LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM | Magellan Diagnostics | 2013-08-20 |
| K052549 | LEADCARE II BLOOD LEAD TESTING SYSTEM | Esa Biosciences, Inc. | 2005-10-06 |
| K971640 | LEADCARE BLOOD LEAD TESTING SYSTEM | Esa, Inc. | 1997-09-09 |
| K936060 | ATOMSPEC GF BLOOD LEAD WORKSTATION | Thermo Jarrell Ash Corp.Div.Thermo Inst. | 1994-09-06 |
Legacy Summary#
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FDA Review#
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