510(k) K822782
- Device
- Acuscreen
- Applicant
- ORTHO DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K822782
- Product code
- GGW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-10-08
- Date received
- 1982-09-14
- Regulation
- 864.7925
- Classification name
- Test, Time, Partial Thromboplastin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 125 Mark Ave. Carpinteria CA US 93013 93013
FDA Registration Numbers#
- 3013660430
- 3003691680
- 2431530
- 8043599
- 3004434070
- 1181055
- 1000340866
- 3037000637
- 9610806
- 1835316
- 1618982
- 2245451
- 9710666
Source Documents#
510(k) summary PDF not indicated by FDA
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| K945940 | COATEST(R) APC(TM) RESISTANCE | Axis-Shield Doc AS | 1995-08-07 |
| K941210 | PTT-LT TEST KIT | American Bioproducts Co. | 1995-03-21 |
| K924370 | STACLOT(R) PNP TEST KIT | American Bioproducts Co. | 1993-08-09 |
| K921684 | PTT-LA TEST KIT | American Bioproducts Co. | 1992-06-09 |
| K915463 | ACTIVATED PARTIAL THROMBOPLASTIN TIME | Sigma Diagnostics, Inc. | 1992-01-23 |
| K902236 | READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT | Biosearch Medical Products, Inc. | 1990-08-14 |