Atlas FDA

SICKLE-STAT HEMOGLOBIN S SCREEN KIT

FDA 510(k) clearance K841272 · decided 1984-04-13

Clearance details

K-number
K841272
Device name
SICKLE-STAT HEMOGLOBIN S SCREEN KIT
Applicant
Clinical Technology Corp.
Decision
Substantially Equivalent
Date received
1984-03-27
Decision date
1984-04-13
Days to decision
17 days
Clearance type
Traditional
Product code
GHM
Device class
2
Regulation number
864.7825
Medical specialty
Hematology
Advisory committee
Hematology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Clinical Technology Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SICKLE-CHEX SOLUBILITY KIT (K023656)Streck Laboratories, Inc.2002-12-30
SICKLE-CHEX (K013316)Streck Laboratories, Inc.2001-11-06
SAS SICKLE CELL TEST (K960947)Sa Scientific, Inc.1996-07-01
HEMOCARD HEMOGLOBIN S (K911981)Isolab, Inc.1991-10-09
HEMOCARD-AS (K910430)Isolab, Inc.1991-04-15
THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT (K872217)Pacific Hemostasis1987-07-31
SICKLE CELL REAGENT SET (K860812)Michclone Associates, Inc.1986-04-11
SICKLE CELL REAGENT SET (K860420)Sterling Diagnostics, Inc.1986-02-24
THROMBO SCREEN SICKLE CELL ASSAY SET (K854079)Pacific Hemostasis1985-10-31
SICKLING HEMOGLOBIN CONTROLS, NORMAL (K842152)Isolab, Inc.1984-09-09
SICKLE-HEME A/S HETEROZYGOUS CONTROL (K842955)Michclone Associates, Inc.1984-08-09
SICKLE CELL REAGENT SET (K842368)Livonia Diagnostics, Inc.1984-07-20

Recalls involving this device

RecordFirmDate
Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the recall (Z-0470-06)Chembio Diagnostic System Inc2006-02-04