510(k) K023656
- Device
- SICKLE-CHEX SOLUBILITY KIT
- Applicant
- STRECK LABORATORIES, INC.
- 510(k) number
- K023656
- Product code
- GHM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-12-30
- Date received
- 2002-10-30
- Regulation
- 864.7825
- Classification name
- Test, Sickle Cell
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL THOMPSON
- Address
- 7002 S 109th St. La Vista NE US 68128 68128
FDA Registration Numbers#
- 1950302
- 1831312
- 1645225
- 2029372
- 1641328
- 9610806
- 1181121
Source Documents#
Other 510(k) Records For Product Code GHM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013316 | SICKLE-CHEX | Streck Laboratories, Inc. | 2001-11-06 |
| K960947 | SAS SICKLE CELL TEST | Sa Scientific, Inc. | 1996-07-01 |
| K911981 | HEMOCARD HEMOGLOBIN S | Isolab, Inc. | 1991-10-09 |
| K910430 | HEMOCARD-AS | Isolab, Inc. | 1991-04-15 |
| K872217 | THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT | Pacific Hemostasis | 1987-07-31 |
| K860812 | SICKLE CELL REAGENT SET | Michclone Associates, Inc. | 1986-04-11 |
| K860420 | SICKLE CELL REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-24 |
| K854079 | THROMBO SCREEN SICKLE CELL ASSAY SET | Pacific Hemostasis | 1985-10-31 |
| K842152 | SICKLING HEMOGLOBIN CONTROLS, NORMAL | Isolab, Inc. | 1984-09-09 |
| K842955 | SICKLE-HEME A/S HETEROZYGOUS CONTROL | Michclone Associates, Inc. | 1984-08-09 |
| K842368 | SICKLE CELL REAGENT SET | Livonia Diagnostics, Inc. | 1984-07-20 |
| K841272 | SICKLE-STAT HEMOGLOBIN S SCREEN KIT | Clinical Technology Corp. | 1984-04-13 |
| K841170 | SICKLE HB ASSAY | Isolab, Inc. | 1984-04-04 |
| K831871 | SICKLE-HEME A/S CONTROLS & A/A CONTROL | Anco Medical Reagents & Assoc. | 1983-07-28 |
| K820642 | SICKLE-CHECK | Panmed, Inc. | 1982-04-14 |
Legacy Summary#
summary
FDA Review#
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